Trial Information

Summary: SARC 011, N021157: SARC Global Collaboration: Phase II Trial of R1507, A Recombinant Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Patients with Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas

You have/your child has been asked to participate in this research study because you are/your child is at least 12 years of age and have/has a soft tissue or bone sarcoma that has spread to the point where it is no longer curable by surgery or standard therapy. Eligible diagnoses include Ewing’s sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and subtypes alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma or myxoid liposarcoma. The purpose of this research study is to evaluate the safety and effectiveness of R1507. Repeat blood samples will be taken before and after the first dose of R1507 is given to study the levels of R1507 that stay in the body over time. Tumor tissue will be collected or biopsies will be obtained for laboratory tests to confirm the diagnosis of sarcoma and to study the effect of the drug on tumor cells. PET Scans will be done before and after the first treatment to see if the effects of R1507 can be seen earlier than on other scans. Your/your child’s treatment on this study is expected to last for as long as your/your child’s tumor is not growing and you are/your child is not having any unmanageable side effects. After your/your child’s treatment on this study is over, your/your child’s medical condition will continue to be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: October 6, 2008 at 3:02:28 PM