A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma
- 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
- 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
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
Primary Purpose: Treatment
Pamela Z. New, MD
University of Texas Health Science Center at San Antonio
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Henry Ford Hospital||Detroit, Michigan 48202|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|