Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
- Registration Number
- NCT00083070
- Lead Sponsor
- Children's Oncology Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Temozolomide Therapy temozolomide -
- Primary Outcome Measures
Name Time Method Toxicity as assessed by CTCAE 3.0 Pharmacokinetics as assessed by CI, area under the curve (AUC), and half-life (T ½) Maximum tolerated dose and recommended phase II dose
- Secondary Outcome Measures
Name Time Method Antitumor activity Biologic activity and mechanisms of resistance
Trial Locations
- Locations (16)
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Fairview University Medical Center - University Campus
🇺🇸Minneapolis, Minnesota, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada