Trial Information

A Phase II Trial of Pre-Irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)

OBJECTIVES: I. Evaluate the efficacy of carmustine, cisplatin, and etoposide administered
prior to and during radiotherapy in patients with newly diagnosed high grade glioblastoma
multiforme. II. Assess the toxicities of this treatment regimen in this patient population.
III. Assess fatigue, depression, and excessive daytime somnolence in terms of incidence,
duration, and relation to age, tumor type, tumor site, cancer therapy, and symptoms in this
patient population. IV. Evaluate the quality of life of these patients.

OUTLINE: Patients receive pre-irradiation chemotherapy consisting of carmustine IV over 1
hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin
IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 2 courses.
Patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2.
Patients then receive carmustine IV over 1-2 hours every 8 weeks for 4 courses. Treatment
continues in the absence of disease progression or unacceptable toxicity. Quality of life is
assessed before the study, prior to each treatment course, every 4 months for 1 year, every
6 months for 4 years, and then annually for 5 years. Patients are followed every 4 months
for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 15 months.