A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Not Recruiting

Trial ID: NCT00615680


The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.

Official Title

A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.

Stanford Investigator(s)


Inclusion Criteria:

   - progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory
   osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following
   sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor,
   extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;

   - Cohort 3 only: age must be >= 2 and <= 21 years

Exclusion Criteria:

   - clinically significant unrelated systemic illness which would compromise the
   participant's ability to tolerate the investigational agent, or interfere with the
   study procedures or results;

   - known hypersensitivity to any of the components of R1507 or prior hypersensitivity
   reactions to monoclonal antibodies;

   - treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or
   other immunosuppressive agents;

   - current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal
   or specific kinase inhibitor);

   - history of solid organ transplant;

   - other malignant disease diagnosed within the previous 5 years, excluding
   intra-epithelial cervical neoplasia or non-melanoma skin cancer;

   - active central nervous system disease


drug: RG1507

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern

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