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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00880282 |
RATIONALE: 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.
PURPOSE: This phase I trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus in treating young patients with solid tumors that have recurred or not responded to treatment.
Condition | Intervention | Phase |
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Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: cixutumumab Drug: temsirolimus Genetic: gene expression analysis Genetic: protein expression analysis Genetic: western blotting Other: immunologic technique Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 38 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cixutumumab 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.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, immunogenic, and other correlative studies. Samples are analyzed for IGF-1, IGF-2, IGF-BP3, growth hormone, insulin, C-peptides; S6K1, AKT, and associated phosphoproteins; and IGF-1R and insulin-receptor expression and phosphorylation by immunoprecipitation and western immunoblotting.
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
Histologic confirmation may have been made at original diagnosis or relapse
PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 50-100% (patients > 16 years of age) or Lansky PS 50-100% (patients ≤ 16 years of age)
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
PRIOR CONCURRENT THERAPY:
More than 6 weeks since prior major surgery
United States, California | |
Children's Hospital of Orange County | Recruiting |
Orange, California, United States, 92868 | |
Contact: Violet Shen 714-532-8636 | |
United States, District of Columbia | |
Children's National Medical Center | Recruiting |
Washington, District of Columbia, United States, 20010-2970 | |
Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 |
Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
Study ID Numbers: | CDR0000639150, COG-ADVL0813 |
Study First Received: | April 10, 2009 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00880282 History of Changes |
Health Authority: | Unspecified |
unspecified childhood solid tumor, protocol specific |
Antibodies, Monoclonal Antibodies Mitogens |
Insulin Recurrence Immunoglobulins |