Phase III randomized study of chimeric antibody 14.18 (CH14.18) in high risk neuroblastoma following myeloablative therapy and autologous stem cell rescue

eagle-i ID

Resource Type

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1. ClinicalTrials.gov url

   http://clinicaltrials.gov/ct2/show/NCT00026312?term=Phase+III+Randomized+Study+of+Chimeric+Antibody+14.18+%28Ch14.18%29+in+High+Risk+Neuroblastoma+Following+Myeloablative+Therapy+and+Autologous+Stem+Cell+Rescue&rank=1

2. Intervention

   Chimeric human/murine anti-GD2 monoclonal antibody

3. Intervention

   CH14.18

4. Resource Description

   "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."

5. Contact

   Berenberg, Jeffrey

6. PI

   Wilkinson, Robert, M.D.

7. Topic

   neuroblastoma

8. Study Population

   Patients who are between the ages 1-30 years are eligible for this study.

9. Funded by

   Children's Oncology Group

10. Phase

    Phase 3 clinical trial

11. Performed by

    Clinical Protocol & Data Management Shared Resource