Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Inclusion Criteria

• •Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS)
• •Diagnosis will have been established by biopsy or resection within 4 weeks prior to registration
• •Patients must not have received previous radiotherapy to the brain
• •Patients must not have received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, non-EIAEDs, analgesics, and other drugs to treat symptoms or prevent complications
• •Cranial magnetic resonance imaging (MRI) or contrast computed tomography (CT) must have been performed within 21days of study entry; the use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement; if the surgical procedure was a resection, cranial MRI or contrast CT performed with 96 hours of resection is preferred but not required; patients without measurable or assessable disease are eligible
• •Patients must have a plan to begin partial brain radiotherapy within 5-9 days after beginning R115777, and within 35 days (5 weeks) of the surgical procedure that established the diagnosis; radiotherapy must be given at the Radiation Oncology Department of the registering Adult Brain Tumor Consortium (ABTC) institution; radiotherapy must be given by external beam to a partial brain field in daily fractions of 2.0 Gray (Gy), to a planned total dose to the tumor of 60.0 Gy; stereotactic radiosurgery and brachytherapy will not be allowed
• •Patients must be willing to forego other drug therapy against the tumor while being treated with R115777 and temozolomide
• •All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must sign an authorization for the release of their protected health information; patients must be registered with the Adult Brain Tumor Consortium Central Office (ABTC CO) prior to treatment with study drug
• •A life expectancy \> 8 weeks
• •Patients must have a Karnofsky performance status of \>= 60
• •White blood cells (WBC) \>= 3,000/ul
• •Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• •Platelet count of \>= 100,000/mm\^3
• •Hemoglobin \>= 10 gm/dl
• •Bone marrow function tests must be performed within 14 days prior to registration
• •Eligibility level for hemoglobin may be reached by transfusion
• •Serum glutamic oxaloacetic transaminase (SGOT) \< 2 times upper limit of normal (ULN) and the test must be performed within 14 days prior to registration; if above the institutional upper limit of normal but \< 2 times institutional upper limit of normal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks for the individual patient
• •Bilirubin \< 2 times ULN and the test must be performed within 14 days prior to registration; if above the institutional upper limit of normal but \< 2 times institutional upper limit of normal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks for the individual patient
• •Creatinine \< 1.5 mg/dL before starting therapy and the test must be performed within 14 days prior to registration
• •Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
• •Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible
• •No exclusion to this study will be based on race; minorities will actively be recruited to participate
• •Patients must not have active infection
• •Women must not be pregnant or breast-feeding, and women with reproductive potential must practice adequate contraception
• •Patients must not be on chronic Coumadin therapy for prior medical problems (e.g. cardiac valve prophylaxis); this is due to a presumed interaction with Coumadin and ZARNESTRA leading to a significant increase in international normalized ratio (INR); patients who develop or have recently developed a deep venous thrombosis or pulmonary embolism who are on or will take Coumadin will be allowed to participate; however, the investigator should be prepared to monitor patients INR closely