Spots Global Cancer Trial Database for Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
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Trial Identification
Brief Title: Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
Official Title: A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias
Study ID: NCT00083070
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Contact Details
Name: Terzah M. Horton, MD, PhD
Affiliation: Texas Children's Cancer Center
Role: STUDY_CHAIR
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