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Investigator(s):
Lee J. Helman, M.D. Principal Investigator Phone: 301-496-4257 helmanl@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• Histologically or cytologically confirmed recurrent or refractory sarcoma
• Ewing’s sarcoma (Ewing’s family of tumors, ESFT)
• Progressive disease
• Ewing’s sarcoma primary cohort (defined as those patients who have relapsed < 24 months from diagnosis, have received at least two prior chemotherapy programs [one initial and a second for first relapse], and whose tumor is unresectable)
• Ewing’s sarcoma non-primary cohort (defined as those patients who have relapsed > 24 months from diagnosis or have received only one prior chemotherapy program) (no longer recruiting)
• Osteosarcoma (no longer recruiting)
• Synovial sarcoma
• Rhabdomyosarcoma (no longer recruiting)
• Other sarcomas of the following subtypes:
• Alveolar soft part sarcoma
• Desmoplastic small round cell tumors
• Extraskeletal myxoid chondrosarcoma
• Clear cell sarcoma
• Myxoid liposarcoma
• Histological verification of malignancy by central pathology review (to be completed within 6 weeks of study entry)
• ≥ 2 years of age
• Recurrent or refractory tumors with no known curative treatment options
• Life expectancy ≥ 6 weeks
• Karnofsky performance status ≥ 70%
• Measurable disease in two dimensions on CT or MRI
• Patients who have undergone autologous hematopoietic stem cell transplantation (HSCT) will be eligible once they have recovered from all toxicities from therapy (< grade 1 except for alopecia)
• Patients who have received allogeneic HSCT will be eligible 6 months after the procedure, provided there is no evidence of active graft-versus-host disease and immunosuppressive treatment has been discontinued for at least 30 days
• Absolute neutrophil count ≥ 1.5 x 10⁹/L (being ≥ 2 weeks off growth factors)
• Platelet count ≥ 75,000/mL (in patients with documented [confirmed by bone marrow biopsy] bone marrow involvement by neoplasia, no minimum ANC or platelet count is necessary at the discretion of the investigator)
• Total bilirubin ≤ 1.5 x the upper limit of normal for age (ULN)
• ALT/AST (SGPT/SGOT) ≤ 3 x ULN for the reference lab (≤ 5 x ULN for the reference lab in the presence of known hepatic metastasis, adjusted for age)
• Serum creatinine < 1.5 x ULN per age OR creatinine clearance ≥ 70 ml/min/173 m²
• Time elapsed from previous therapy must be ≥ 3 weeks
• Recovered from all prior therapies
• Diabetic patients must have well-controlled disease (no change in medications > 10% for the past 30 days)
• Patients with central nervous system disease are eligible if they meet the following criteria:
• Received radiotherapy or surgery
• No glucocorticoids for ≥ 4 weeks
• No overt evidence of neurological deficit
• ≥ 6 weeks from completion of brain irradiation
• Not pregnant or nursing; fertile patients and their partners must use effective contraception during the study and for 120 days following the last dose of study medication
• No condition that would preclude study participation
• No known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies
• No treatment within the past 2 weeks with the pharmacologic doses of corticosteroids equivalent to 20 mg prednisone daily (or 0.5 mg/kg in patients < 10 years of age) or other immunosuppressive agents
• No current or prior therapy with IGF inhibitor (monoclonal or specific kinase inhibitor)
• No history of solid organ transplant
• No other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin
• No active central nervous system disease
• No concomitant use of any other investigational agent(s)
• Prior use of investigational agent(s) is acceptable if ≥ 3 weeks have elapsed since last dose and no future doses are planned

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Study Outline:

This is an open-label, single-arm, multi-cohort, multicenter, two-stage, Phase II study of R1507 for the treatment of patients with recurrent or refractory sarcoma.

• Patients are stratified according to type of sarcoma
• All patients receive R1507 at a dose of 9 mg/kg once weekly until disease progression, unacceptable adverse event, withdrawal, or death

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.

Reviewed: 6/8/09
Updated: 7/28/09