Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
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.
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.
;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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