COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00004147
- Lead Sponsor
- New Approaches to Brain Tumor Therapy Consortium
- Brief Summary
RATIONALE: COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of COL-3 in treating patients who have progressive or recurrent brain tumors following radiation therapy or chemotherapy.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose, dose limiting toxicity, and safety profile of oral COL-3 alone or when combined with anticonvulsants known to be metabolized by CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme.
* Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics.
* Determine the response rate, disease free survival, and survival in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study of COL-3. Patients are stratified by anticonvulsant (anticonvulsants that cause induction of CYP450 vs anticonvulsants that cause modest or no induction of CYP450 or no anticonvulsant).
* Phase I: Patients receive oral COL-3 daily. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
* Phase II: Patients receive oral COL-3 daily at the MTD from the phase I portion of this study.
Patients are followed every 2 months until death.
PROJECTED ACCRUAL: A total of 15-18 patients will be accrued for phase I of the study and a total of 35 patients will be accrued for phase II of the study at a rate of 3 patients per month.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States