A Phase I Study of Concurrent Multi-modality Treatment for Patients With Relapsed Malignant Glioma Using Permanent I-125 Interstitial Seeds and Dose Escalation of Gliadel 3.85% Carmustine (BCNU) Polymer Wafers
OBJECTIVES: I. Assess the toxic effects of concurrent permanent iodine I 125 interstitial
seed implants and polifeprosan 20 with carmustine implant (Gliadel wafers) in patients with
recurrent or refractory malignant glioma. II. Assess preliminary efficacy of this regimen in
terms of progression free survival and overall survival of these patients. III. Assess
impact of this regimen on the quality of life and performance status of these patients. IV.
Assess site of tumor progression following this regimen in these patients. V. Assess the
relationship between progression free survival and the MIB-1 proliferative index of the
resected malignant glioma.
OUTLINE: This is a dose escalation study. Patients undergo craniotomy with the intent to
obtain a complete resection of enhancing tumor. Following maximum tumor removal, iodine I
125 seeds and up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) are
implanted into the resected tumor cavity. Cohorts of 6 patients each receive increasing
numbers of Gliadel wafers placed into the tumor cavity. Quality of life is assessed at
baseline, then every 3 months, and at tumor progression. Patients are followed monthly until
death.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 18
months.
Interventional
Primary Purpose: Treatment
Robert E. Albright, MD
Study Chair
Barrett Cancer Center
United States: Federal Government
UCMC-98724
NCT00003876
April 1999
May 2004
Name | Location |
---|---|
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |