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A Phase II Trial of R1507 for People with Recurrent Sarcoma

[Protocol 07-166]

Full Title :

SARC GLOBAL COLLABORATION: A PHASE II TRIAL OF R1507 A RECOMBINANT HUMAN 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 (SARC011 ROCHE N021157)

Purpose :

Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can produce side effects, and the duration of benefit is often short. As a result, doctors are looking for new treatments. The purpose of this study is to find out the safety and usefulness of a new medicine called R1507 in patients with Ewing sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas that have returned or spread despite previous treatment.

R1507 is a new type of targeted chemotherapy that attacks a specific protein in cells called the "insulin-like growth factor 1 receptor." Researchers hope that by blocking this protein, they can prevent tumor growth or cause tumors to shrink. Specifically, they will examine how many people are still receiving R1507 after 18 weeks of treatment.

R1507 is given intravenously once a week, every week.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of Ewing sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcoma that has returned or spread despite previous treatment.
• At least 3 weeks must have passed since completion of prior therapy, and patients must have recovered from any side effects.
• Patients must be age 12 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Robert Maki at 212-639-5720.