A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias
- 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
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
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and recommended phase II dose
Terzah M. Horton, MD, PhD
Texas Children's Cancer Center
United States: Federal Government
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|Children's Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15213|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|
|Fairview University Medical Center - University Campus||Minneapolis, Minnesota 55455|
|Stanford Cancer Center at Stanford University Medical Center||Stanford, California 94305|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Baylor University Medical Center - Houston||Houston, Texas 77030-2399|