Trial Search Results

A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

This study will evaluate the efficacy and safety of R1507 in participants with recurrent or refractory sarcoma. Eight cohorts of sarcoma participants will be studied in parallel. Cohort 1: Ewing's sarcoma primary cohort defined as participants who have relapsed less than or equal to (<=) 24 months from diagnosis, received at least two prior chemotherapy programs and are unresectable. Cohort 2: Ewing's sarcoma non-primary (secondary) cohort defined as participants who have relapsed greater than or equal to (>=) 24 months from diagnosis or have only received one prior chemotherapy program. Cohort 3: Expanded Ewing's sarcoma defined as participants with recurrent or relapse regardless of prior number of salvage regimens and regardless of time of relapse. Cohort 4: participants with osteosarcoma. Cohort 5: Participants with synovial sarcoma. Cohort 6: Participants with rhabdomyosarcoma Cohort 7: Participants with alveolar soft part sarcoma (7a), desmoplastic small round cell tumors (7b), extraskeletal myxoid chondrosarcoma (7c), clear cell sarcoma (7d), myxoid liposarcoma (7e). Cohort 8: Participants with unspecified sarcoma diagnosis. Participants in the expanded Ewing's sarcoma Cohort 3 will receive 27 milligrams (mg)/kilogram (kg) every 3 weeks intravenously (IV). All other participants will receive R1507 9 mg/kg IV weekly. The anticipated time on study treatment is until disease progression or unacceptable adverse events, withdrawal or death.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Collaborator: Sarcoma Alliance for Research through Collaboration

Stanford Investigator(s):

Intervention(s):

  • Drug: RG1507

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

2 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern
6507256413
Not Recruiting