A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme
- Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by
adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly
diagnosed glioblastoma multiforme.
- Estimate the frequency of toxicity associated with this treatment regimen.
OUTLINE: This is an open-label, multicenter study.
- Induction chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week,
for 6 weeks. During the same 6 weeks, patients also receive oral temozolomide once
daily. Four weeks later, patients are evaluated for disease progression. Patients with
progressive disease are removed from the study. Patients with no progressive disease
proceed to maintenance therapy.
- Maintenance therapy: Patients receive oral temozolomide once daily on days 1-5 (week
1). Patients also receive poly ICLC intramuscularly three times a week in weeks 2-8.
Courses repeat every 9 weeks in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Myrna Rosenfeld, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|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|
|Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham||Birmingham, Alabama 35294|