Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
Condition: Glioblastoma Multiforme/Anaplastic Astrocytoma
MeSH terms: Glioblastoma; Astrocytoma
Intervention: temozolomide; Hypofractionated radiation therapy; Intensity-modulated radiation therapy
Intervention description: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment; Patients will undergo HIMRT; Patients undergo HIMRT
Intervention MeSH terms: Temozolomide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult giant cell glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult glioblastoma; GBM/AA

Summary:

      RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy
      that delivers a high dose of radiation directly to the tumor may kill more tumor cells and
      cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may
      kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when
      given together with radiation therapy in treating patients with newly diagnosed glioblastoma
      multiforme or anaplastic astrocytoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic
             oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not
             involving the brain stem or optics chiasm, diagnosed following biopsy or tumor
             removal.

          -  Age > 18 years

          -  Given written consent

          -  Adequate bone marrow reserve(hemoglobin > 10 grams, Absolute neutrophil count > 1500 /
             mm3, platelets > 100,000/ mm3)

          -  Normal renal function(BUN < 24 mg/dL, Creatinine < 1.3 mg/dL)

          -  Normal liver function(Total Bilirubin < 1.5 mg/dL, SGPT/ALT < 60 U/L)

        Exclusion Criteria:

          -  Have a Karnofsky score of < 60 [Appendix B] or age < 18 years.

          -  Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic
             astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas,
             gliosarcoma.

          -  Tumors located in the brainstem or optic chiasm.

          -  Prior radiation therapy to the brain

          -  Prior chemotherapy within the past 6 weeks.