A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme

Inclusion 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