Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
Glioblastoma Multiforme
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) by biopsy or resection within the past 3 months PATIENT CHARACTERISTICS: Karnofsky performance status ≥ 60% Absolute neutrophil count ≥ 1500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 mg/dL Transaminases ≤ 4 times above the upper limits of the institutional normal Creatinine ≤ 1.7 mg/dL Not pregnant or breast-feeding Patients must agree to follow acceptable birth control methods to avoid conception Negative pregnancy test Patients must have a Mini Mental State Exam score of ≥ 15 No serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin Patients who have been free of disease (any prior malignancy) for ≥ five years are eligible for this study Patients requiring ongoing therapy for psychoses with antipsychotic medications at the time of enrollment will be ineligible PRIOR CONCURRENT THERAPY: Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor Prior glucocorticoid therapy is allowed Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with poly ICLC plus temozolomide on this protocol No other concurrent therapy for their tumor (i.e., chemotherapeutics or investigational agents) Patients who have received prior Gliadel wafers are not eligible for this study No concurrent prophylactic filgrastim (G-CSF) No concurrent electron, particle, implant, or stereotactic radiosurgery boost
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Winship Cancer Institute of Emory University
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts General Hospital Cancer Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Wake Forest University Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Experimental
Treatment Arm
RT + TMZ 6wks, followed by poly ICLC, temozolomide, radiation: radiation therapy