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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01016015 |
Purpose
RATIONALE: 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 in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temsirolimus together with cixutumumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temsirolimus together with cixutumumab works in treating patients with locally advanced, metastatic, or recurrent soft tissue sarcoma or bone sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: cixutumumab Drug: temsirolimus Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Temsirolimus (CCI-779, NSC 683864) and IGF-1 Receptor Antibody Cixutumumab (IMC-A12, NSC 742460) in Patients With Metastatic Sarcomas |
| Estimated Enrollment: | 172 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to IGF1-receptor status and disease (IGF1R-positive soft tissue sarcoma vs IGF1R-positive bone sarcoma vs IGF1R-negative sarcoma).
Patients receive cixutumumab 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.
Patients may undergo blood and tissue sample collection periodically for correlative studies.
After completion of study treatment, patients are followed up for ≥ 4 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed sarcoma of soft tissue or bone
Measurable disease by RECIST criteria
Patients at MSKCC must consent to tumor biopsies before treatment and after the second week of therapy
PATIENT CHARACTERISTICS:
Serum glucose ≤ 120 mg/dL (nonfasting or fasting)
No concurrent uncontrolled illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior major surgery and recovered
More than 4 weeks since prior glucocorticoid therapy administered for > 5 days
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Gary K. Schwartz, MD 212-639-8324 | |
| Principal Investigator: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Robert Maki, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01016015 History of Changes |
| Other Study ID Numbers: | CDR0000659358, MSKCC-09097 |
| Study First Received: | November 17, 2009 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Unspecified |
|
metastatic osteosarcoma recurrent osteosarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma recurrent adult soft tissue sarcoma |
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |