Spots Global Cancer Trial Database for Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
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Trial Identification
Brief Title: Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
Official Title: A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors
Study ID: NCT00070473
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed disodium in treating young patients with recurrent solid tumors.
Detailed Description: OBJECTIVES: Primary * Determine the maximum tolerated dose of pemetrexed disodium in children and adolescents with refractory solid tumors. * Determine the dose-limiting toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine, preliminarily, the antitumor activity of this drug in these patients. * Correlate the presence of the C677T polymorphism of the methylenetetrahydrolate reductase gene, the presence of a polymorphism in the enhancer region of the thymidylate synthase (TS) gene promoter (2R and 3R tandem repeats), the presence of a polymorphism within one of those repeats, and the presence of a functional polymorphism in the 3'-untranslated region with toxicity in patients treated with this drug. * Correlate homocysteine and methylmalonic acid levels at study entry with toxicity in patients treated with this drug. * Correlate various gene expression profiles with response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1 year.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
NCI - Pediatric Oncology Branch, Bethesda, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Contact Details
Name: H. Stacy Nicholson, MD, MPH
Affiliation: OHSU Knight Cancer Institute
Role: STUDY_CHAIR
Name: Linda C. Stork, MD
Affiliation: Doernbecher Children's Hospital at Oregon Health and Science University
Role: STUDY_CHAIR
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