Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
- 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
- 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
Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers
Mark W. Kieran, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15213|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Texas Children's Cancer Center||Houston, Texas 77030-2399|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|