SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00015899
- Lead Sponsor
- Pediatric Brain Tumor Consortium
- Brief Summary
RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors.
- Detailed Description
OBJECTIVES:
* Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors.
* Estimate the maximum tolerated dose of this drug in these patients.
* Describe the pharmacokinetics of this drug with and without dexamethasone in these patients.
* Investigate the efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral SCH 66336 twice daily. Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is predicted that 20% of patients may experience dose-limiting toxicity. An additional 6 patients are treated at the determined MTD.
Patients are followed within 30 days of the last administration of the study drug and then for up to 3 months.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers Maximum tolerated dose of SCH 66336 Four weeks Pharmacokinetics of SCH 66336
- Secondary Outcome Measures
Name Time Method Tumor response to SCH 66336
Trial Locations
- Locations (9)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Texas Children's Cancer Center
🇺🇸Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States