Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
Condition: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma
MeSH terms: Glioblastoma; Gliosarcoma
Intervention: radiation therapy; carboxyamidotriazole; pharmacological study
Intervention description: Undergo radiotherapy; Given orally; Correlative studies
Intervention MeSH terms: Carboxyamido-triazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop
      growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining
      radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the
      effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have
      newly diagnosed supratentorial glioblastoma multiforme.
    

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