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|  University of Hawai'i Manoa |
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| University of Hawai'i Manoa |
The Clinical Protocol and Data Management Shared Resource (CPDM) is a component of the Center’s Clinical Trials Unit that provides central management and oversight of all clinical trials activities of the Center.
The Shared Resource provides a range of management and quality control functions that are essential for conducting clinical trials research in Hawaii’s decentralized community practice setting. It includes a central location for all cancer protocols, a centralized database of protocol-specific data, an updated list of currently active protocols for the use of Center investigators, and status reports of protocols. It provides a centralized organization for activating and monitoring protocols throughout Hawaii’s multiple community offices and medical centers involving several Institutional Review Boards (IRBs). Quality control functions include: insuring subject safety and compliance with federal requirements through the Data and Safety Monitoring plan, insuring staff competency through training for research nurses, CRAs, clinical trials assistants and community office, clinic, and hospital staff engaged in Hawaii’s cancer clinical trials enterprise, and insuring recruitment of underserved minorities through focused outreach activities.
Member:
Wilkinson, Robert, M.D.
Role:
Professor
This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.
Protocol ID: URCC-06-05
Surgery is the primary treatment for most cases of kidney cancer. While surgery alone often cures patients with early stage disease, individuals with more advanced disease have an increased risk of cancer recurrence after surgery.
In this trial, patients who have tumors that can be surgically removed and who are at high risk for recurrence are given sunitinib (Sutent®), sorafenib (Nexavar®), or a placebo as postoperative (adjuvant) therapy. Patients given the placebo will be receiving the current standard of care for their condition, which is no adjuvant therapy.
Sunitinib and sorafenib are targeted therapies that block cell proliferation and the growth of new blood vessels to tumors (a process called angiogenesis). Angiogenesis is important for the growth and spread of malignant kidney tumors and blocking it may help prevent the growth of cancer cells that remain after surgery.
The primary objectives of this study are to determine the toxicities and tolerability of bortezomib in combination with standard-relapse acute myeloid leukemia (AML) therapy (idarubicin/cytarabine or etoposide/high-dose cytarabine) in pediatric and young adult patients with relapsed or primary-refractory or secondary AML, and to estimate the complete response rate to the Arm A and Arm B regimens.
This is a multicenter, dose-escalation study of bortezomib. Patients are stratified according to anthracycline-equivalent cumulative exposure (≤ 400 mg/m² vs > 400 mg/m²). Patients are assigned to 1 of 2 groups.
Group 1 (efficacy phase, patients with ≤ 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive idarubicin IV over 15 minutes on days 1-3, low-dose cytarabine IV continuously over days 1-7, and bortezomib IV on days 1, 4, and 8.
Group 2 (dose-finding phase and efficacy phase, patients with > 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive etoposide IV over 1 hour on days 1-5, high-dose cytarabine IV over 1 hour twice daily on days 1-5, and bortezomib IV on days 1, 4, and 8.
All patients receive intrathecal cytarabine prior to courses 1 and 2.
In both arms, treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for at least 5 years.
Most women with ovarian cancer are not diagnosed until the cancer has spread to the peritoneum (the lining of the abdominal cavity) or beyond. The standard treatment for advanced ovarian cancer is surgery, both to establish the stage and type of cancer and to remove as much cancerous tissue as possible, followed by chemotherapy with drugs such as carboplatin and paclitaxel. Despite aggressive treatment, however, the survival rate for advanced ovarian cancer remains low.
In this trial, women who have undergone initial surgery for ovarian cancer or primary peritoneal cancer (which is biologically similar to ovarian cancer) will receive standard intravenous chemotherapy. Some women will also receive concurrent treatment with a biologic agent called bevacizumab. Bevacizumab blocks the activity of a protein called vascular endothelial growth factor, which helps tumors form new blood vessels needed for continued growth and spread. Following chemotherapy, some of the bevacizumab-treated women will receive additional courses of bevacizumab.
This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.
"This laboratory study is collecting, analyzing, and storing tissue samples from patients with non-Hodgkin's lymphoma."
"This research study is collecting and storing blood samples from patients with previously untreated non-Hodgkin lymphoma."
This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer.
"The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma."
RATIONALE: Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.
PURPOSE: This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia.
RATIONALE: Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.
"The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory."
"This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer."
Supratentorial PNETs and High Risk Medulloblastoma’s that occur in children less than 36 months age at diagnosis are fast growing brain tumors that if not treated are always fatal. Treatment for these tumors usually involves surgery to remove as much of the tumor as possible followed by chemotherapy (anti-cancer drug therapy) and sometimes radiation. Many of these tumors do go away with the treatment but may come back once treatment has stopped. The goal of this study is to find a treatment which will kill the tumor cells that remain after surgery and hopefully cure the child.
At this time there is no known standard proven treatment for these tumors but two small experimental research studies have treated children less than 36 months with induction chemotherapy followed with intense chemotherapy and stem cell rescue with some tumors responding to the treatments. These two studies used the same chemotherapy drugs but the second study added methotrexate during the induction period.
The purpose of this study is to compare the two experimental treatment regimens to see if one is better for children with high risk medulloblastoma or supratentorial PNET.
Subjects will receive one of two different treatment plans.Subjects will be assigned to either Arm A, which is the 4 drug induction chemotherapy, or Arm B, which is the same 4 drug induction chemotherapy as in Arm A with the addition of methotrexate. The difference in the regimens is the addition of the drug methotrexate to the induction therapy to determine if adding the drug will prove more effective in treating the tumor. After the induction the two arms of the study are the same. If the tumor goes away with the induction therapy, the subjects will have 3 cycles of consolidation chemotherapy followed by stem cell rescue. If the tumor has gotten smaller, but is not completely gone or does not change size after induction chemotherapy, subjects may have another surgery to remove the rest of the tumor. Once recovered from surgery, subjects will have 3 cycles of consolidation chemotherapy followed by stem cell rescue.
Another goal of this study is to do research tests on some of the tumor tissue that is taken out during surgery. These tests are being done to better understand things about the tumor cells such as the kinds of proteins in them and if they have any genetic differences. In addition some blood may need to be collected for these tests.
Nearly 500 children are diagnosed with AML every year and half are cured with standard therapy. In other words, half of the children diagnosed with AML and treated as described above remain with no signs of cancer (remission) for five years. The overall goal of this study is to see if we can increase this cure rate without causing more serious side effects of therapy.
Researchers want to know if they can improve the cure rate for AML by adding a new chemotherapy drug, called gemtuzumab, to the standard chemotherapy treatments. gemtuzumab has been studied in adults with AML in combination with standard chemotherapy drugs. It has also been studied in small groups of pediatric patients. These studies have determined what dose of gemtuzumab can be given safely with other chemotherapy drugs.
Subjects (people participating in the study) will receive one of two different treatment plans.
Subjects will be assigned to either Arm A, the current standard therapy, or Arm B, which is considered the experimental arm. Arm B uses the current standard therapy in combination with gemtuzumab. Gemtuzumab has been given to children with AML before but it has not yet been compared to the current therapy to see if it improves outcome.
Another goal of this study is to determine which children with AML need a stem cell transplant and which children do not. During intensification treatment, the study doctors will assign subjects to either receive more chemotherapy, or a stem cell transplant. This is decided based on two factors: 1) the subject’s risk of AML coming back, and 2) if they have a matched stem cell donor available.
We will also be studying how well children with Down syndrome do on the standard therapy. Down syndrome patients may respond differently to chemotherapy drugs than patients without Down syndrome. This study will give study doctors information about how Down syndrome patients respond to standard therapy.
Subjects with Down syndrome enrolled on this study will not be randomized, and will be assigned to Arm A, the standard therapy. Prior studies of children with Down syndrome and AML show that they are often more responsive to treatment but have more complications than children without Down syndrome. Therefore, there needs to be more experience gained in treating children with Down syndrome and they will not receive the additional experimental drug in this study.
"This research study is looking at bone marrow and blood samples from patients with leukemia or other hematopoietic cancers."
The purpose of this study is to determine if adding a medication by the name of bevacizumab to the current standard chemotherapy of cancer-reducing medications, namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence (called disease-free survival) compared to standard chemotherapy alone. Bevacizumab has been approved by the FDA (Food and Drug Administration) for use in the chemotherapy treatment of patients with colorectal cancer. The outcome for those patients showed improvement with the use of this drug. In this study, Bevacizumab is considered investigational because it has not received FDA approval as yet for use in breast cancer. However, this drug has been extensively studied in previous breast cancer clinical trials. These studies showed improved results in patients whose breast cancer recurred. Based on these results, it is hoped that using this medication or this type of medication earlier in treatment of the disease may lead to better outcomes for this group of patients.
This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases. Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy.
The overall goal of this study is to compare the effects, good and/or bad, of the chemotherapy drugs carboplatin and isotretinoin on subjects with high risk medulloblastoma and to find out if one or both are better than standard therapy alone.
The purpose of this study is:
To find out if giving the drug carboplatin along with radiation therapy is more effective than giving radiation therapy alone.
To find out if the drug isotretinoin can improve the survival of subjects with high risk medulloblastoma.
To measure any effects that the different types of treatment have on the quality of life (general well-being).
To measure the brain function of subjects (measuring intelligence, memory, language, nonverbal skills, attention, and academic achievement) and the relationship between level of brain function and their quality of life.
Another purpose of the study which is optional is:
To identify markers in the DNA of tumor tissue that will help us know how best to treat patients in the future and to pick the most promising new therapies for future studies.
This trial evaluates the addition of novel therapeutic agents to the intensive chemotherapy used in the previous COG trial for metastatic rhabdomyosarcoma. As in the previous trial, patients enrolled in this study will be treated with an intensified chemotherapy regimen. This study will assess the feasibility of adding new agents to the chemotherapy backbone. Patients in Pilot 1 will have cixutumumab added to their weekly chemotherapy. Patients in Pilot 2 will have temozolomide added to their vincristine/irinotecan cycles. Patients in Pilot 3 will receive both cixutumumab and temozolomide with the chemotherapy.
Osteosarcoma is the most common cancerous bone tumor in children and young adults. Early studies of a medication called zoledronic acid have shown that it may be useful in treating metastatic osteosarcoma. In this clinical trial, study doctors would like to find out if adding zoledronic acid to the standard treatment for metastatic osteosarcoma will help more patients survive this disease. Study participant will get the standard set of chemotherapy drugs: cisplatin, doxorubicin, methotrexate, ifosfamide, and etoposide. In addition to the standard drugs, everyone will get another drug called zoledronic acid at either dose level 1, dose level 2, dose level 3, or dose level 4. The most effective dose of zoledronic acid for children is not yet known, but the doses we are testing were shown in other studies to be safe for adults. This study will test the safety and feasibility of adding zoledronic acid to the standard chemotherapy. This study will determine the maximum tolerated dose (MTD) of zoledronic acid when used in combination with this standard chemotherapy regimen over a 36-week treatment period. It is divided into 2 stages: 1) Induction - chemotherapy treatment before the tumor is taken out and 2) Maintenance - chemotherapy treatment after the surgery. The first 6 children enrolled on the study will get dose level 2. If the side effects are not severe, the next group of 6 children enrolled will get dose level 3. Once again, if the side effects are not severe, the next group of 6 children enrolled will get dose level 4, the highest dose found to be safe for adults. Some children will be enrolled at dose level 1 while the study doctors are checking to be sure that there are no severe side effects at the higher dose levels. We expect that the information learned from this study will benefit other patients in the future.
It is not yet known whether giving cyclophosphamide together with doxorubicin is more effective than giving paclitaxel alone in treating breast cancer. This randomized phase III trial is studying cyclophosphamide and doxorubicin to see how well they work compared to paclitaxel in treating women with invasive breast cancer.
In earlier studies different therapies have been used to treat patients with high risk acute lymphoblastic leukemia (ALL). Approximately 70% of high risk patients will be cured with the best available therapies. The goal of this study is to increase this cure rate without increasing side effects of the therapy.
The experimental treatments being tested here are based on information we have learned from earlier studies. This study will use a known chemotherapy regimen that has been very effective for treating children with high risk ALL and test whether two changes to this treatment can cure more patients without increasing side effects:
The aim of the first change is to test two steroid drugs: whether 14 days of dexamethasone is tolerated without an increased number of severe side effects and is better than 28 days of prednisone (standard treatment) in decreasing the number of leukemia cells during the first month of treatment.
The aim of the second change is to determine whether giving higher doses of methotrexate, another cancer fighting drug, will work better than giving it on a schedule that starts with a lower dose and increases with each of the later doses during a middle phase of treatment.
Results from previous studies have shown that patients can be separated into two groups based on their response to the first month of treatment. Rapid Early Responders (RER) respond quickly to treatment. Slow Early Responders (SER) respond to treatment more slowly. In this study those patients that are SER will be assigned to receive more courses of heavier treatment that those patients that are considered RER, since SER are at greater risk of the leukemia returning.
Minimal Residual Disease (MRD) is the measurement of very small amounts of leukemia cells. We know from previous studies that this measurement can be an important indicator of how well a patient is likely to do on therapy. By measuring the MRD level on Day 29 we hope to find out that it will be sensitive enough to identify which patients need more intense treatment. In this study RER patients will include those with a negative MRD result on Day 29 of therapy, and SER patients will include those with a positive MRD result on Day 29 of therapy.
"This laboratory study is collecting and storing samples of tissue and blood from young patients with Hodgkin's lymphoma."
The purpose of this study is to find out if IMC-A12 can stop cancer from growing or cause it to get smaller for a period of time, and to learn more about the biology of IMC-A12.
"The goals of AALL0622 are to assess the safety and feasibility of substituting dasatinib for imatinib in the high-risk ALL protocol chemotherapy backbone, to determine whether intensive chemotherapy plus dasatinib will lead to a 3-year event free survival of at least 60% in patients with Ph+ALL and a good early response to therapy, to assess the effect of these changes on levels of MRD present at end of Induction and end of Consolidation Block 2 compared to AALL0031 and to measure the 3-year EFS for all patients (Standard and High-Risk) receiving dasatinib."
Children with an initial late bone marrow or combined relapse, or an early isolated extramedullary relapse of acute lymphoblastic leukemia (ALL) have relatively poor overall outcome, with an event-free survival for early CNS and late marrow of 30-60%. EF for early testicular relapse is also < 60%. Combined, this group of patients has an intermediate prognosis compared to patients with early marrow relapse or late isolated extramedullary relapse. The major cause of failure in all of these subgroups (including isolated extramedullary relapse) is subsequent relapse in the marrow. The overall goal of this study is to establish the efficacy of an intensive chemotherapy regimen for patient with intermediate-risk relapse of childhood B-precursor ALL.
Researchers want to know if they can improve the cure rate for intermediate-risk relapse ALL by intensive dosing of vincristine, to the standard chemotherapy treatments.
Study participants will be randomized to receive one of two different treatment plans, either Arm A, which is the current standard therapy, or Arm B, which is considered the experimental arm. Arm A uses the current standard dose therapy Vincristine. Vincristine has been given safely to children with ALL before but it has not been compared to the higher dose.
Another goal of this study is to compare the outcomes of patients treated with chemotherapy vs. matched sibling family donor hematopoietic stem cell transplantation (SCT) for those with eligible donors.
We will also be studying the use of DNA arrays to characterize patterns of gene expression that predict treatment failure, and to compare gene expression profiles at the time of relapse with those at initial diagnosis to gain an understanding of the pathways that may be involved in disease resistance and to determine whether common polymorphisms in candidate genes are associated with the frequency of vincristine adverse effects (peripheral neuropathy, SIADH, or constipation) and with anti-leukemic response (level of end-induction MRD).
This clinical trial is studying cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer.
"The purpose of this study is to collect and store blood and bone marrow samples from patients with hematologic cancer to be tested in the laboratory."
"This clinical trial is studying carcinogens in lung tissue from smokers and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer."
"This Phase III, randomized, open-label trial will determine whether the regimens of chemotherapy plus trastuzumab plus bevacizumab improve invasive disease-free survival (IDFS) relative to the regimens of chemotherapy plus trastuzumab. Secondary aims include determining whether the addition of bevacizumab to chemotherapy plus trastuzumab will improve disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), and distant recurrence-free interval (DRFI). The benefit of adding bevacizumab for IDFS, DFS, OS, RFI, and DRFI will also be evaluated for each of the two chemotherapy regimens. The cardiac and non-cardiac toxicities of each of the regimens will also be evaluated."
"The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Although most people in this study enjoy good health, some may be at risk for certain health conditions. We are collecting information from as many participants as possible in order to determine if they or their offspring are at risk for adverse medical conditions. If there is more than one case of Wilms tumor in a given family, we plan to work with geneticists to try to estimate heritability and recurrence risks."
Protocol ID: POG 9442
The primary aims of this study are to determine whether the regimen of AC → weekly paclitaxel (WP) plus trastuzumab plus lapatinib yields a greater rate of pCR than the regimen of AC → WP plus trastuzumab and to determine whether the regimen of AC → WP plus lapatinib yields a greater rate of pCR than the regimen of AC → WP plus trastuzumab.
Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function in young patients with cancer. This study is looking at neuropsychological and behavioral testing in young patients with medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET).
In this trial, the hybrid regimen ABVE-PC*, modified from both DBVE-PC regimen of POG 9425 and BEACOPP of CCG 59704 will be utilized. This study will attempt to achieve optimal balance by using a regimen that is more dose dense (dose intensity per week) than POG 9425, but less dose intensive (cumulative dose of chemotherapy) than CCG 59704. We will test a response-based approach wherein rapid early responders (RER) to the first 2 cycles of ABVE-PC* will be treated with 2 additional cycles of ABVE-PC* and risk-adapted radiation therapy (RT), whereas slow early responders (SER) will receive 2 cycles of ifosfamide/vinorelbine (IFOS/VINO) (a combination proven to be effective in the AHOD00P1 study) in addition to 2 more cycles of ABVE-PC* and risk-adapted RT. Since a subset of patients with high risk HL can be successfully cured with retrieval therapy, this study will test the hypothesis that this regimen will result in excellent long term "second event" free survival.
"This randomized clinical trial is studying two different symptom management programs to see how well they work compared with usual care in patients with recurrent or persistent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer."
This randomized phase II trial is studying how well giving paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery.
This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.
This study is investigating patient, physician, and nurse factors associated with entry onto clinical trials and finishing treatment in patients with primary or recurrent uterine, endometrial, or cervical cancer.
This phase II trial is studying how well giving gemcitabine together with cisplatin works in treating patients with stage I non-small cell lung cancer that was removed by surgery.
"This phase II trial is studying the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma."
Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.
This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries.
The purpose of this study is to estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma, and to evaluate the value of inhibin for predicting response.
RATIONALE: Sorafenib tosylate and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well giving sorafenib tosylate together with erlotinib hydrochloride works in treating patients with locally advanced, unresectable, or metastatic gallbladder cancer or cholangiocarcinoma.
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells.
This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer.
Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.
This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.
The B-46-I/07132 study, a multicenter, open-label, randomized Phase III, adjuvant therapy trial, will compare the value of adding bevacizumab to a non-anthracycline-based chemotherapy regimen relative to the same chemotherapy without bevacizumab and relative to an anthracycline-based chemotherapy regimen in women with resected node-positive or high-risk node-negative, HER2-negative breast cancer. This trial will determine whether the addition of bevacizumab to a regimen of docetaxel and cyclophosphamide (TCB) improves invasive disease-free survival relative to docetaxel and cyclophosphamide alone (TC). A secondary aim will be to determine whether the addition of bevacizumab to TC improves invasive disease-free survival compared to a regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC). Other secondary aims include whether TCB improves disease-free survival, overall survival, and recurrence-free interval relative to TC alone and to TAC. The toxicities of the three regimens will also be compared.
Patients in the B-46-I/07132 study will be randomized to one of three treatment regimens: Group 1 patients will receive 6 cycles of TAC administered every 21 days (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2); Group 2 patients will receive 6 cycles of TC administered every 21 days (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2); and Group 3 patients will receive 6 cycles of TCB every 21 days with bevacizumab therapy continuing every 21 days after completion of chemotherapy until 1 year following the first dose (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2, and bevacizumab 15 mg/kg). Primary prophylaxis with pegfilgrastim or filgrastim is required for Group 1 patients (optional for patients in Groups 2 and 3). Patients will also receive adjuvant radiation therapy as clinically indicated and endocrine therapy for hormone receptor-positive tumors.
Tumor samples will be submitted for correlative science studies to evaluate predictors of study therapy benefit. Submission of a tumor sample is a study requirement for all patients.
This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy.
The purpose of this study is to determine if one or both of the proposed intraperitoneal chemotherapy regimens improves the progression-free survival (PFS) event rate compared to standard intravenous chemotherapy for first-line treatment of patients diagnosed with advanced stage ovarian, peritoneal or fallopian tube cancer. If both IP regimens significantly improve the PFS event rate compared to the standard regimen, then a second study objective is to determine whether IP cisplatin and IV paclitaxel on day one plus IP paclitaxel on day eight improves the PFS event rate when compared to the IP carboplatin and IV paclitaxel.
This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
"Children eligible for this trial are those with high risk neuroblastoma who have been responding to and are completing chemotherapy, surgery, radiation therapy, and stem cell transplant and have been treated on high risk neuroblastoma protocols. The purpose of this companion study is to compare two different treatments aimed at maintaining or improving patients’ response to high risk treatment.
This study involves the use of an investigational agent, ch14.18 (chimeric human/murine anti-GD2 monoclonal antibody). Ch14.18 is a protein made in cultured cells using recombinant DNA technology to humanize antibody made by mice. The chimeric human/murine ch14.18 binds well to neuroblastoma cells and to tumor cells that are positive for GD2, and helps destroy cancer cells. It binds very little to normal tissue. GD2 is a sugar lipid that is strongly expressed on the surface of neuroblastoma cells."
This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
This randomized phase III trial is studying sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with locally advanced or metastatic liver cancer.
Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery.
This randomized phase III trial is studying chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.
This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.
Germ cell tumors are tumors arising from primitive germ cells or the cells that would become sperm in the male or an egg in a female. These tumors can occur in the gonads (ovaries in females or the testes in males) and in other areas of the body such as the brain, chest or abdomen. All malignant germ cell tumors will be on this study excluding brain. The overall goal of this study is to see if we can identify patients who have no further need of therapy after a complete resection at surgery, and among those who need chemotherapy, if we can maintain excellent survival rates with a reduced amount of chemotherapy.
If a germ cell tumor is completely resected during surgery, chemotherapy may not be necessary. Researchers want to know if they can (1) treat Stage I, testicular/ovarian germ cell tumors by using surgery and close observation, reserving chemotherapy for those who relapse (2) reduce the amount of chemotherapy (3 cycles instead of 4) and give the chemotherapy over a shorter interval (3 days instead of 5) (3) to determine any biologic factors that are unique in the tumors of patients with these tumors
"This phase III trial is studying giving lestaurtinib together with combination chemotherapy to see how well it works compared to combination chemotherapy alone in treating infants with newly diagnosed acute lymphoblastic leukemia."
This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.
This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.
This randomized phase III trial is studying pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer.
This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.
There are three primary objectives of this study, as follows: To compare the relative safety and efficacy of augmented Berlin-Frankfurt-Münster-86 multiagent chemotherapy with or without nelarabine in younger patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-NHL).
To compare the relative safety and efficacy of interim maintenance therapy comprising high-dose methotrexate (with leucovorin calcium rescue) and mercaptopurine vs escalating-dose methotrexate (without leucovorin calcium rescue) and pegaspargase in these patients.
To gain preliminary data on the use of nelarabine in patients with high-risk T-NHL and its effect on long-term survival.
Secondary objectives are as follows: To determine the relative safety and efficacy of withholding radiotherapy in patients with low -risk T-ALL and administering prophylactic cranial radiotherapy in patients with intermediate- or high-risk T-ALL.
To characterize T-NHL biologic samples using conventional immunophenotyping, cytogenetic analysis, detection of activating Notch 1 mutations, comparative genomic hybridization (CGH), and gene expression profiling, and correlate these with long-term survival and identify potential targets for future therapy.
New tests may provide information about which patients are more likely to benefit from chemotherapy.
This randomized phase III trial is trying to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.
This clinical trial is studying osteonecrosis of the jaw in patients with cancer who are receiving zoledronic acid for bone metastases.
RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: This randomized phase III trial is studying radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well they work when given before surgery in treating patients with resectable rectal cancer. It is not yet known whether radiation therapy and either capecitabine or fluorouracil is more effective with or without oxaliplatin in treating rectal cancer.
Thes purpose of this research study is to: 1) Find out what effects (good and bad) the study treatment has on the cancer. 2)Compare four different study treatment combinations to see if one is better 3)Find out what effects this study has on patient's quality of life. Because of recent research by NCCTG, the standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin®). However, not all patients with HER2+ breast cancer do better with trastuzumab, so investigators are trying to find out why. GW572016 (lapatinib, brand name: Tykerb®) is a drug that is taken every day by mouth. This study is comparing trastuzumab to lapatinib and each drug alone to two combinations of trastuzumab and lapatinib. The four treatments being studied here are: Group 1 - The standard treatment - trastuzumab alone for one year Group 2 - Lapatinib alone for one year Group 3 - Trastuzumab for 12 weeks followed by a 6 week break, and then lapatinib for 34 weeks Group 4 - Trastuzumab and lapatinib together for one year.
This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.
This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I non-small cell lung cancer.
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given alone or together with vandetanib.
PURPOSE: This randomized phase II trial is studying docetaxel given together with or without vandetanib to see how well it works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
This randomized phase II trial is studying how well pixantrone dimaleate works in treating patients with HER2-negative metastatic breast cancer.
Vinorelbine ditartrate and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread or carry tumor-killing substances to them. Bevacizumab may also stop the growth of rhabdomyosarcoma by blocking blood flow to the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective when given together with bevacizumab or temsirolimus in treating rhabdomyosarcoma.
This randomized phase II trial is studying how well giving panitumumab together with gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in treating patients with metastatic pancreatic cancer.
Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol and tamoxifen may fight endometrial cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether temsirolimus is more effective when given alone or together with megestrol and tamoxifen in treating endometrial cancer.
This randomized phase II trial is studying temsirolimus to see how well it works with or without megestrol and tamoxifen in treating patients with advanced, persistent, or recurrent endometrial cancer.
RATIONALE: Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.
This randomized phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer.
Purpose: It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.
This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
Cisplatin is a chemotherapy medicine that is used for many types of childhood cancer. Cisplatin can cause side effects to the blood and kidney systems. Cisplatin may also cause a side effect called ototoxicity. Ototoxicity is damage to the hearing system that causes hearing loss or ringing in the ears (tinnitus). This hearing loss can be permanent. Sodium thiosulfate (STS) is a medicine that may prevent this kind of hearing loss. The goal of this research study is to evaluate if STS can prevent hearing loss in participants receiving cisplatin chemotherapy for newly diagnosed cancers.
It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer.
This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.
RATIONALE: It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.
PURPOSE: This randomized phase III clinical trial is studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.
RATIONALE: It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying giving lenalidomide and dexamethasone together with bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma.
Purpose: It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.
This randomized phase III trial is studying the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, recurrent, or persistent cervical cancer.
Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known whether giving paclitaxel once every three weeks is more effective than giving paclitaxel once a week.
This randomized phase III clinical trial is studying two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.
This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.
RATIONALE: When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression.
PURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.
This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.
Rhabdomyosarcoma is the most common soft tissue sarcoma in children and adolescents, accounting for nearly 250 cases of childhood cancer in the United States each year. Despite the use of multiple drug therapies, only 65% of intermediate-risk patients are expected to be cured.
The overall goal of this study is to see if we can increase this cure rate without causing more serious side effects of treatment. Researchers want to know if they can improve the cure rate for Intermediate-Risk Rhabdomyosarcoma by treating with surgery to remove as much tumor as possible, radiation therapy and chemotherapy. Participants in the study will receive one of two different treatment plans.
Another goal of this study is to compare a new schedule of giving radiation therapy at week 4 compared to the standard schedule of starting at week 13. Other studies of radiation timing for other cancers have shown improved outcomes when radiation was given earlier in the treatment plan. A slightly lower dose of cyclophosphamide will also be given to compare side effects of the higher standard dose.
The standard anti-cancer drugs used to treat patients with osteosarcoma are doxorubicin, cisplatin, and methotrexate (together called MAP therapy). In previous research studies using MAP, it was found that if the tumor cells are almost all destroyed (about 90% or more, called a good response) by MAP, there is a good chance that the tumor can be cured by continuing to use these standard drugs. If the tumor cells are not as easily killed by MAP (less than 90% of the cells killed, called a poor response), the chance of cure is not as good, meaning the tumor is more likely to return later.
For children and adolescents who do not have a good tumor response to MAP, this study aims to find out if adding two other common anti-cancer drugs (ifosfamide and etoposide) will help cure more patients.
For children and adolescents who have a good tumor response to MAP therapy, study doctors would like to know if adding a “biologic” drug, interferon, after MAP, will help make sure the tumor cells do not return later.
The aims of this study are:
To see if the addition of ifosfamide and etoposide to MAP chemotherapy will help cure patients who have a poor tumor response to MAP alone.
To see if the addition of interferon after MAP chemotherapy can help improve cure rates in children and adolescents who have a good tumor response to standard chemotherapy.
RATIONALE: Tadalafil may help prevent erectile dysfunction in patients with prostate cancer that have been treated with radiation therapy. It is not yet known whether tadalafil is more effective than a placebo in preventing erectile dysfunction.
PURPOSE: This randomized phase III trial is studying tadalafil to see how well it works compared with a placebo in preventing erectile dysfunction in patients with prostate cancer treated with radiation therapy.
PURPOSE: This randomized phase II trial is studying temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or recurrent non-small cell lung cancer.
"RATIONALE: Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at kidney tumors in young patients."
RATIONALE: G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.
Studies done in both children and adults with Non-rhabdomyosarcoma soft tissue sarcomas have shown that the amount of treatment a patient needs may be based on the “risk group” of the tumor. Tumors are assigned a risk group based on features that influence how they behave.
For NRSTS, the risk group is based on the type of cells in the tumor (the grade of the tumor), the size of the tumor, if the tumor has spread to other areas of the body, and how much of the tumor can be taken out by surgery.
Patients with tumors in the low risk group may be cured with mild treatment, in some cases only surgery.
Patients with tumors in the intermediate and high-risk groups may need more treatment, including anti-cancer drugs (chemotherapy) and high energy X-ray therapy (radiation therapy).
This study is being done to find out:
if treatment based on each subject's level of risk will get rid of the tumor and
if lessening the treatment for lower risk subjects will decrease the side effects of treatment and still get rid of the tumor.
The purpose of this study is to find out if the overall dose of radiation to the brain and spine can be reduced without decreasing the survival rates. The study will also look at whether the volume of radiation given during the “boost” to the specific area of the tumor can safely be reduced without decreasing survival.
Additional goals of this study are to:
To identify whether children who receive less radiation and have their tumors come back share similar characteristics.
To reduce the effects of radiation on the child’s hearing, ability to learn, and hormone function.
To look at whether children who receive lower doses of radiation have fewer long-term side effects of treatment.
To perform studies on removed tumor in the laboratory that may predict prognosis.
Older children with low grade gliomas that have come back after surgery or are causing problems are often treated with radiation therapy. Younger children are usually treated first with chemotherapy, but if the tumor comes back following completion of therapy, then they often receive radiation therapy as well. Radiation therapy can cause severe side effects. New types of radiation therapy can treat a smaller area of the brain and doctors think that patients who receive this type of radiation might have fewer side effects.
The purpose of this study is to test the safety and effectiveness of this “smaller field radiation” in patients with low grade gliomas. This study will also try to determine if the results of a special test performed on the removed tumor tissue predict how the tumor may respond to radiation. Finally, this study will also evaluate the functional status and quality-of-life of children with low grade gliomas who receive this treatment.
This study is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia.
Protocol ID: URCC-0701
This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma.
This study is being done to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just tamoxifen alone in premenopausal women. It will also test whether a newer hormone drug called exemustane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. In addition the side effects of these different treatments will be studied.
This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer.
Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen* or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.
This randomized phase III trial is studying giving tamoxifen* or letrozole together with bevacizumab to see how well it works compared with tamoxifen* or letrozole alone in treating women with stage III or stage IV breast cancer.
This randomized phase III trial is studying temozolomide and radiation therapy to compare how well they work when given together with or without bevacizumab in treating patients with newly diagnosed glioblastoma. (gliosarcoma closed to accrual as of 07-13-10).
There is no current standard treatment for recurrent/refractory medulloblastoma/PNET. Recurrent/refractory medulloblastoma/PNET is difficult to treat successfully. Previous studies have shown that the combination of the medicines temozolomide and irinotecan have activity against recurrent medulloblastoma/PNET. This study will use temozolomide and irinotecan to try to improve or slow the growth of recurrent/refractory medulloblastoma/PNET. Some of the participants in this study will also receive the medicine bevacizumab. Bevacizumab works differently than the medications temozolomide and irinotecan. Adding bevacizumab to treatment with temozolomide and irinotecan is experimental.
Overview : Bevacizumab and sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving different combinations of bevacizumab, sorafenib, and temsirolimus may be more effective than bevacizumab alone in treating metastatic kidney cancer.
Purpose: This randomized phase II trial is studying different combinations of bevacizumab, temsirolimus, and sorafenib to see how well they work compared with bevacizumab alone in treating patients with metastatic kidney cancer.antineoplastic combined chemotherapy protocols.
This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.
Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer.
The overall goals of this research study are:
- to find out if children less than 2 years old with a small Stage I Wilms tumor can be safely treated with surgery alone followed by careful observation.
- to find out if some children with a higher risk of having their tumor return (Stage I or II Wilms tumor with the LOH change) will benefit from the addition of a chemotherapy agent called doxorubicin. Doxorubicin will be added to the current standard treatment regimen of two drugs called vincristine and actinomycin.
- to find out if there are things about the Wilms tumor cells that might tell us why standard treatment does not get rid of the tumor for all III Wilms tumor patients without the LOH change. Note that children with stage III Wilms tumor with the LOH change will be offered participation in a different study called AREN0533.
Also, treatment information from this study will be linked to the tumor samples collected as part of the AREN03B2 study. Researchers hope that they will be able to tell if any other biological or genetic factors can help predict the best treatment for patients with these renal tumors.
PURPOSE: This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system.
Recent studies done in adults with an NPC-type tumor have shown that chemoradiotherapy works better than radiation therapy followed by chemotherapy. Studies in adults have also shown that the drug amifostine can help prevent the loss of, and thickening of, saliva. This side effect of radiation therapy to the head and neck causes dryness of the mouth which leads to dental problems, problems swallowing and infections. This study will use radiation therapy, chemotherapy and chemoradiotherapy.
The goals of this study are:
To see if a combination of chemotherapy followed by chemoradiotherapy works better at treating children with advanced NPC than the standard therapy used in adults, which is chemoradiotherapy only.
To see how well amifostine protects children against dry mouth when given daily before radiation therapy.
In this study, the risk level for the disease coming back after treatment is either very low, low, intermediate or high. Subjects are treated according to the risk group they are in.
Other questions that researchers want to answer in this study are:
Can a rating system called Pretreatment Extent of Disease (or PRETEXT) be used to decide if a tumor can be removed by surgery? Also, do different doctors give the same or different PRETEXT ratings when looking at the same patient’s tumor on a scan?
Are there other factors that are present in children with hepatoblastoma that can be used to develop better treatments?
For low-risk hepatoblastoma: Is it possible to give only 2 cycles of Cisplatin, 5-Fluorouracil and Vincristine, also called C5V (instead of the standard 4 cycles) in addition to taking out the tumor with surgery and still have good treatment success rates?
For intermediate-risk hepatoblastoma: Can doxorubicin (chemotherapy) be given with C5V without causing too many side effects?
For intermediate-risk and high-risk hepatoblastoma: Is it possible for subjects to be referred by their doctor to a center with experts in liver transplant surgery by the end of 2 cycles of chemotherapy? And is it then possible for these subjects to have their liver transplant done at the end of 4 cycles of chemotherapy?
For high-risk hepatoblastoma: Are vincristine and irinotecan (types of chemotherapy) useful chemotherapy drugs for treating high-risk hepatoblastoma?
One specific type of Hodgkin disease is known as Lymphocyte Predominant Hodgkin Disease (LPHD). The standard treatment for Hodgkin disease is chemotherapy and radiation therapy (high-dose x-rays).
Most patients are cured of their Hodgkin disease, but some people have side effects from the therapy later in life. These kinds of side effects are often called “late effects.” Late effects can include problems with growth, organ function, and sometimes a second kind of cancer. Late effects may be caused by either chemotherapy or radiation. Researchers believe that if some people can be treated with less therapy or with surgery alone, then these people might have fewer late effects.
The goals of this study are to see if late effects can be lessened or prevented by using less chemotherapy and radiation. Another goal is to find out if using less chemotherapy and radiation to treat LPHD will still show high cure rates.
Some subjects (people participating in the study) will get no chemotherapy or radiation if only one lymph node was affected by LPHD and a surgeon completely removed it.
Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors.
The overall goal of this study is to find out:
if subjects with Wilms tumor that has spread only to their lungs can be treated without having radiation therapy to their lungs. Subjects whose lung tumors go away completely after the first six weeks of standard chemotherapy will not have to have radiation therapy
if subjects with Wilms tumor that has spread only to their lungs whose lung tumors do not go away after the first six weeks of standard chemotherapy for Wilms tumor can be treated by using two additional chemotherapy drugs, plus radiation therapy
if subjects who have Wilms tumor that has spread to other parts of the body in addition to or instead of in the lungs, can be treated by using two additional chemotherapy drugs along with the standard drugs, and radiation therapy
if some genetic information about the tumor cells can help us put subjects in the experimental treatment group.
This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia.
Results of past research studies with low-risk rhabdomyosarcoma patients show that using the three chemotherapy medicines (including cyclophosphamide) helps to cure more patients, but cyclophosphamide at the high doses that were used in the past studies can cause late effects.This study is being done to find out the most effective treatment with the least amount of therapy that will still cure patients with low risk rhabdomyosarcoma.
Purpose:
This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma.