Recurrent Osteosarcoma Clinical Trial
Official title:
A Phase 2 Study of Temsirolimus (CCI-779, NSC 683864) and IGF-1 Receptor Antibody Cixutumumab (IMC-A12, NSC 742460) in Patients With Metastatic Sarcomas
This phase II trial studies how well temsirolimus and cixutumumab works in treating patients with locally advanced, metastatic, or recurrent soft tissue sarcoma or bone sarcoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth by blocking the ability of tumor cells to grow and spread. Giving temsirolimus with cixutumumab may be an effective treatment for soft tissue or bone sarcoma.
PRIMARY OBJECTIVES:
I. To determine the proportion of patients progression-free at 12 weeks (progression free
survival [PFS], defined as Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
complete response [CR] + partial response [PR] + stable disease [SD]) with (A) Insulin-like
growth factor (IGF)-1receptor (R)+ soft tissue sarcomas; (B) IGF-1R+ bone tumors; or (C)
IGF-1R(-) sarcomas, who are treated weekly with intravenous A12 (cixutumumab) and
temsirolimus.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (defined as CR + PR). II. To determine the overall
survival. III. To determine the correlation of clinical outcome with pre- and post-treatment
IGF-1R pathway related markers in plasma (pre and post therapy), archived tissue, and pre-
and post-treatment tumor biopsies.
OUTLINE:
Patients receive cixutumumab intravenously (IV) over 60 minutes and temsirolimus IV over 30
minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 4 weeks.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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