Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias|
- Maximum tolerated dose and recommended phase II dose [ Designated as safety issue: Yes ]
- Toxicity as assessed by CTCAE 3.0 [ Designated as safety issue: Yes ]
- Pharmacokinetics as assessed by CI, area under the curve (AUC), and half-life (T ½) [ Designated as safety issue: No ]
- Antitumor activity [ Designated as safety issue: No ]
- Biologic activity and mechanisms of resistance [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Study Completion Date:||June 2008|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
|Experimental: Temozolomide Therapy||
- 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.
- 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.
|United States, California|
|Stanford Cancer Center at Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Minnesota|
|Fairview University Medical Center - University Campus|
|Minneapolis, Minnesota, United States, 55455|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216-4505|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|SUNY Upstate Medical University Hospital|
|Syracuse, New York, United States, 13210|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-9786|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Baylor University Medical Center - Houston|
|Houston, Texas, United States, 77030-2399|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Hopital Sainte Justine|
|Montreal, Quebec, Canada, H3T 1C5|
|Study Chair:||Terzah M. Horton, MD, PhD||Texas Children's Cancer Center|