Treatment > Carmustine · Irinotecan · Temozolomide Clinical Trials

Meeting Abstract

Novel use of Gliadel for gliomas

Allan H Friedman, Sunil Agarwal, Brandon Evans, Amy Walker, Sandra Tourt-Uhlig, David Reardon, Mary L Affronti, Deborah Allen, Rodney Beason, Sridharan Gururangan, Susanne Jackson, Roger McLendon, Jennifer Quinn, Jeremy Rich, John Sampson, Valerie Stafford-Fox, Karen Ziegler, Darell D Bigner, Henry Friedman

Duke University Medical Center, Durham, NC; Guilford Pharmaceuticals, Baltimore, MD; Pharmacia & Upjohn, Kalamazoo, MI; Schering-Plough, Kenilworth, NJ.

The Brain Tumor Center at Duke is conducting three trials utilizing Gliadel for the treatment of high-grade and low-grade gliomas. 
Two trials are currently being used for malignant glioma. 

A phase II trial of Gliadel plus temozolomide is being evaluated in patients with recurrent malignant glioma. 
Patients undergo surgical resection and placement of Gliadel wafers followed by temozolomide at a dose of 200 mg/m²/day for 5 days with cycles repeated every 4 weeks. 
Eight patients have been accrued to date with the following progression free survival: 48+, 36+, 24, 20+, 16, and 16 weeks, respectively. 
One patient refused therapy after 2 cycles. 
One patient was removed from study due to home physician advice. 

The second protocol, for patients with recurrent malignant glioma, is a phase I trial of Gliadel plus CPT-11. 
Patients undergo surgical resection with placement of Gliadel wafers followed by CPT-11 administered weekly x 4 with a 2 week rest. 
Thirteen patients have been accrued to date with the highest CPT-11 dose to date 100 mg/m². 

The third protocol is a phase II trial of Gliadel for patients with recurrent low-grade glioma. 
Seven patients have been treated to date with the following progression free survivals: 40+, 36+, 26+, 27, 15, 7, and 4 months, respectively. 
In summary, this trial is building on the known anti-glioma activity of Gliadel with new multi-modality treatment strategies.

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