Feasible dose analysis of zoledronic acid with concurrent chemo in the reaction of newly diagnosed metastatic osteosarcoma

eagle-i ID

Resource Type

Properties

1. Intervention

   Zoledronic acid

2. Resource Description

   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.

3. Contact

   Berenberg, Jeffrey

4. PI

   Wilkinson, Robert, M.D.

5. Topic

   osteosarcoma

6. Study Population

   Patient age: up to age 18

7. Funded by

   Children's Oncology Group

8. Phase

   Phase 0 clinical trial

9. Performed by

   Clinical Protocol & Data Management Shared Resource