Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
About this trial
This is an interventional treatment trial for Adult Giant Cell Glioblastoma
Eligibility Criteria
Inclusion Criteria: Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) Patients must have measurable or non-measurable tumor on the post operative, pretreatment MRI/CT scan (within two weeks of starting treatment) Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed Patients must have recovered from the immediate post-operative period and be maintained on a stable steroid regimen (no increase for the last five days) Absolute neutrophil count >= 1500/mm^3 Platelets >= 100,000/mm^3 Hemoglobin concentration >= 9.0 g/dl Creatinine =< 1.7mg/dL Total bilirubin =< 1.2 mg/dl Transaminases =< 2 times above the upper limits of the institutional normal Estimated life expectancy greater than 2 months Patients must give informed consent and understand the investigational nature of this study and its potential risks and benefits Patients, if female and of childbearing potential must have a negative serum beta-hCG test and must not be breast feeding; all patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception Patients must have a Karnofsky performance status of >= 60% No other serious concurrent infection or other medical illness should be present which would jeopardize the ability of the patient to receive the drug outlined in this protocol with reasonable safety Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ; patients with prior malignancies must be disease-free for >= five years Exclusion Criteria: Patients must be able to comply with prescribed medical care Prior therapy for the brain tumor (except surgery) Prior treatment with antineoplastic agents, including CAI
Sites / Locations
- University of Alabama Birmingham
- Moffitt Cancer Center
- Emory University/Winship Cancer Institute
- Johns Hopkins University
- Henry Ford Hospital
- Wake Forest University
- University of Pennsylavania/Abramson Cancer Center
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Experimental
Treatment (RT and CAI)
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival. Other: pharmacological study, radiation therapy