NCT00070473

Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors

A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	pemetrexed disodium

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-03-01
• Completion: 2008-06-01
• First posted: 2003-10-07
• Last updated: 2014-02-20

Locations

20 sites across 2 countries: United States, Canada