Treatment > Carmustine · Irinotecan

Meeting Abstract

A phase II study of CPT-11 plus BCNU for adults with high grade glioma

Mary L Affronti, David Reardon, Deborah Allen, Rodney Beason, Sridharan Gururangan, Allan Friedman, James Herndon, Susanne Jackson, Roger McLendon, Jennifer Quinn, Jeremy Rich, John Sampson, Amy Walker, Darell D Bigner, Henry Friedman

Duke University Med Ctr, Durham, NC; Pharmacia Corp, Kalamazoo, MI

We previously determined the maximal tolerated dose of weekly CPT-11 with fixed dose BCNU as 225 mg/m2 for malignant glioma patients on concurrent glucouronidation-enhancing anticonvulsants (GEAC) (dilantin, phenobarbitol and tegretol) and 125 mg/m2 for those not on GEACs. 
We now present preliminary results of a phase II study for malignant glioma patients given 100 mg/m2 of BCNU every 6 weeks on the same day as the first CPT-11 dose. 
CPT-11 is administered intravenously weekly at 225 mg/m2/dose for patients on GEACs, and 125 mg/m2/dose those not on GEACs. 
Patients received BCNU plus 4 weekly doses of CPT-11 followed by a 2 week rest. 
Among thirty-nine patients with recurrent tumors (glioblastoma multiforme (GBM), n=28; anaplastic astrocytoma (AA), n=9; anaplastic oligodendroglioma, n=2) 1 patient had a partial response (PR), 17 had stable disease (SD), 15 had progressive disease (PD) and 6 are too early (TE). 
Toxicity grade 3 included hematologic (n=6), infection (n=6), diarrhea (n=5) and thrombosis (n=1). 
Twenty newly diagnosed patients have been treated (GBM, n=14; AA, n=6). 
One had a CR, 2 had a PR, 4 had SD, 8 had PD and 5 are TE. 
Toxicity ³ grade 3 among newly diagnosed patients included diarrhea (n=6), hematologic (n=3), infection (n=3), thrombosis (n=4) and pulmonary (n=2). 
Four of 48 evaluable patients (8%) achieved a PR or CR; 21/48 (44%) achieved SD for 2 or more cycles. 
These results indicate that BCNU plus CPT-11 is a promising regimen for patients with malignant glial tumors.

© Copyright 2002 American Society of Clinical Oncology