Spots Global Cancer Trial Database for Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
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Trial Identification
Brief Title: Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
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
Study ID: NCT01016015
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
University of Michigan University Hospital, Ann Arbor, Michigan, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Albert Einstein College of Medicine, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
SUNY College at Old Westbury, Old Westbury, New York, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: William Tap
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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