NCT00083070

Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia

A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (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 temozolomide, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of temozolomide in pediatric patients with refractory or recurrent leukemia. * Determine the toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine the antitumor activity of this drug in these patients. * Determine the biologic activity and mechanism(s) of resistance to this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18-24 months.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	temozolomide

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-09-01
• Completion: 2008-06-01
• First posted: 2004-05-17
• Last updated: 2014-02-20

Locations

16 sites across 2 countries: United States, Canada