Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
- Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00070473
- Lead Sponsor
- Children's Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event Free Survival Length of study
- Secondary Outcome Measures
Name Time Method Dose Limiting Toxicity Length of study Any patient who experiences DLT at any time during protocol therapy will be considered evaluable for toxicity. Patients not experiencing DLT must complete a full cycle of therapy to be considered potentially evaluable for toxicity. Patients who are not evaluable for toxicity will be replaced.
Maximum Tolerated Dose Length of study The MTD will be that dose at which fewer than one-third of patients experience DLT
Trial Locations
- Locations (20)
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, 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
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
NCI - Pediatric Oncology Branch
🇺🇸Bethesda, Maryland, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Fairview University Medical Center - University Campus
🇺🇸Minneapolis, Minnesota, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States