![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | May 6, 2001 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | January 2002 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00015899 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors | ||||
Official Title † | Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors | ||||
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:
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 and then for up to 3 months. PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study. |
||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Brain and Central Nervous System Tumors | ||||
Intervention † | Drug: lonafarnib | ||||
Study Arms / Comparison Groups | |||||
Publications * | Kieran MW, Packer RJ, Onar A, Blaney SM, Phillips P, Pollack IF, Geyer JR, Gururangan S, Banerjee A, Goldman S, Turner CD, Belasco JB, Broniscer A, Zhu Y, Frank E, Kirschmeier P, Statkevich P, Yver A, Boyett JM, Kun LE. Phase I and pharmacokinetic study of the oral farnesyltransferase inhibitor lonafarnib administered twice daily to pediatric patients with advanced central nervous system tumors using a modified continuous reassessment method: a Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2007 Jul 20;25(21):3137-43. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
||||
Gender | Both | ||||
Ages | up to 21 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00015899 | ||||
Responsible Party | |||||
Secondary IDs †† | PBTC-003, SPRI-P02201 | ||||
Study Sponsor † | Pediatric Brain Tumor Consortium | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
|
||||
Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | July 2004 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |