Spots Global Cancer Trial Database for Cixutumumab and Temsirolimus in Treating Younger Patients With Solid Tumors That Have Recurred or Not Responded to Treatment
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Trial Identification
Brief Title: Cixutumumab and Temsirolimus in Treating Younger Patients With Solid Tumors That Have Recurred or Not Responded to Treatment
Official Title: A Phase I Study of IMC-A12 (Anti-Insulin-Like Growth Factor-I Receptor Monoclonal Antibody) in Combination With CCI-779 (Temsirolimus) in Pediatric Patients With Recurrent or Refractory Solid Tumors
Study ID: NCT00880282
Study Description
Brief Summary: This phase I trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus in treating younger patients with solid tumors that have recurred or not responded to treatment. 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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and recommended Phase II dose of IMC-A12 (anti-insulin growth factor-1 receptor monoclonal antibody) (cixutumumab) administered as an intravenous infusion once weekly in combination with CCI-779 (temsirolimus) administered intravenously once weekly to children with refractory solid tumors. II. To define and describe the toxicities of IMC-A12 in combination with temsirolimus administered on this schedule. III. To characterize the pharmacokinetics of IMC-A12 in combination with temsirolimus in children with refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of the combination of IMC-A12 and temsirolimus within the confines of a Phase I study. II. To assess the biologic activity of IMC-A12 by assessing: changes in insulin-like growth factor receptor (IGFR) expression and phosphorylation and insulin-receptor expression and phosphorylation in peripheral blood mononuclear cells (PBMNC). III. To assess the biological activity of temsirolimus by measuring levels of phosphorylated (phosphor)-ribosomal protein S6 kinase, 70kDa, polypeptide 1 (S6K1), phosphor-protein kinase B (AKT), phosphor-eukaryotic translation initiation factor 4 gamma, 1 (eIF4G) in PBMNC. IV. To assess the incidence of IGFR expression as well as mechanistic target of rapamycin (mTOR) pathway activation in recurrent or refractory solid tumors of childhood. OUTLINE: Patients receive cixutumumab intravenously (IV) over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up periodically.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Childrens Hospital of Orange County, Orange, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Indiana University Medical Center, Indianapolis, Indiana, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Mark O Hatfield-Warren Grant Magnuson Clinical Center, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Columbia University Medical Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
Contact Details
Name: Maryam Fouladi
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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