A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Stopped early · Phase 2

Conditions studied: Sarcoma

In brief

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.

Key facts

Study ID

NCT00642941

Run by

Hoffmann-La Roche

People needed

317

Starts

2007-12-18

Expected to finish

2014-02-19

Last updated by the study team

2021-02-03

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology — Los Angeles, California, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• Stanford Comprehensive Cancer Center — Stanford, California, United States
• Washington Cancer Institute; Washington Hospital Center — Washington D.C., District of Columbia, United States
• Kootenai Medical Center — Coeur d'Alene, Idaho, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• NIH/NCI — Bethesda, Maryland, United States
• Massachusetts General Hospital; Dana Farber Partnes Cancer Center — Boston, Massachusetts, United States
• Dana Farber Partners Can Ctr — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Nebraska Methodist Hospital; Onc Hem West — Omaha, Nebraska, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Albert Einstein College of Medical Pediatrics; Department of Pediatrics — The Bronx, New York, United States
• Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy — Charlotte, North Carolina, United States
• Oregon Health and Science University Cancer Institute — Portland, Oregon, United States
• Pennsylvania Oncology Hema Asc — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Texas Children's Cancer Center; Baylor College of Medicine — Houston, Texas, United States
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute; Orthopedic Center — Salt Lake City, Utah, United States
• Peter Maccallum Cancer Institute; Medical Oncology — Melbourne, Victoria, Australia
• BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada
• Institut Bergonie; Oncologie — Bordeaux, France

Full record on ClinicalTrials.gov

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