SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00015899|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 14, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: lonafarnib||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Official Title:||Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||March 2007|
- Drug: lonafarnib
Other Name: SCH 66336
- Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers
- Maximum tolerated dose of SCH 66336 [ Time Frame: Four weeks ]
- Pharmacokinetics of SCH 66336
- Tumor response to SCH 66336
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015899
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94143-0372|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|United States, Texas|
|Texas Children's Cancer Center|
|Houston, Texas, United States, 77030-2399|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Study Chair:||Mark W. Kieran, MD, PhD||Dana-Farber Cancer Institute|