NCT01016015

Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Osteosarcoma
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Osteosarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	Cixutumumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Temsirolimus	Given IV

Timeline

• Start date: 2009-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2009-11-18
• Last updated: 2015-07-30
• Results posted: 2015-07-30

Locations

24 sites across 2 countries: United States, Canada