A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma
- Evaluate the safety and tolerability of escalating doses of efaproxiral (RSR13) when
administered concurrently with carmustine in patients with progressive or recurrent
- Determine the maximum tolerated dose (MTD) of RSR13 when administered with carmustine
in this patient population.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Estimate the efficacy of this regimen at the MTD in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of
Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over
1-2 hours on day 1. Treatment repeats every 6 weeks for a maximum of 6 courses in the
absence of unacceptable toxicity or disease progression.
Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of
12 patients experience dose-limiting toxicity. Once the MTD is determined, additional
patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase
Patients are followed at 6 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for the phase I portion of this
study. A maximum of 47 patients will be accrued for the phase II portion of this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
Pamela Z. New, MD
The University of Texas Health Science Center, Houston
United States: Federal Government
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|