Temozolomide and Radiation Therapy in Treating Patients With Gliomas
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: Temozolomide; Radiation therapy
Intervention description: Concurrent chemoradiotherapy temozolomide given 75 mg/m^2 daily during radiotherapy for 6 weeks.
Post-Radiation Temozolomide given 150 mg/m2 daily on days 1-5 every 28 days with cycle one beginning 28 days post-radiotherapy. In the absence of grade 3 or 4 adverse events, a single dose escalation to 200 mg/m2/day could be attempted for cycle 2 and, if tolerated, that dose should continue for all subsequent cycles. Cycles were repeated every 28 days (+/- 2 days) for a total of 12 cycles.; One treatment of 1.8 Gy given daily, 5 days per week (over 6 weeks) for a total dose of 54.0 Gy.
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult diffuse astrocytoma; adult oligodendroglioma; adult mixed glioma

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. Giving temozolomide together
      with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation
      therapy works in treating patients with low-grade gliomas.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed* supratentorial glioma of 1 of the following histologies:

               -  Astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic)

               -  Oligodendroglioma

               -  Oligoastrocytoma Note: *Histologic atypia allowed provided no other histologic
                  features (i.e., frequent mitoses, endothelial proliferation, and/or acute
                  necrosis) that would result in a designation of anaplastic astrocytoma,
                  anaplastic mixed oligodendroglioma or oligoastrocytoma, or glioblastoma
                  multiforme are present

          -  Unifocal or multifocal disease

          -  World Health Organization (WHO) grade II disease

          -  Neurofibromatosis allowed

          -  Surgical biopsy or resection for tumor tissue sampling required within the past 12
             weeks

               -  Tissue block or core biopsy available for O6-methylguanine-DNA methyltransferase
                  analysis and tissue banking

               -  Patients who have only had a stereotactic biopsy are not eligible

          -  Must have ≥ 3 of the following risk factors:

               -  Age 40 and over

               -  Largest preoperative tumor diameter ≥ 6 cm

               -  Tumor crosses the midline

               -  Astrocytoma-dominant tumor subtype

               -  Preoperative Neurological Function Status > 1

          -  No other low-grade glioma histologies, including any of the following:

               -  Pilocytic astrocytoma

               -  Subependymal giant cell astrocytoma of tuberous sclerosis

               -  Subependymoma

               -  Pleomorphic xanthoastrocytoma

               -  Presence of a neuronal element, such as ganglioglioma

               -  Dysneuroembryoplastic epithelial tumor

          -  No high-grade glioma, including any of the following:

               -  Anaplastic astrocytoma

               -  Glioblastoma multiforme

               -  Anaplastic oligodendroglioma

               -  Anaplastic oligoastrocytoma

          -  No tumors in any non-supratentorial location, including any of the following:

               -  Optic chiasm

               -  Optic nerve(s)

               -  Pons

               -  Medulla

               -  Cerebellum

               -  Spinal cord

          -  No evidence of disease progression to spinal meninges or noncontiguous cranial
             meninges (i.e., leptomeningeal gliomatosis) by MRI of the spine or cerebrospinal fluid
             (CSF) cytology

               -  MRI of the spine or CSF cytology are not required for patients without symptoms
                  of spinal/cranial meningeal disease progression

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Total bilirubin ≤ 1.5 mg/dL

          -  Serum glutamate oxaloacetate transaminase (SGOT) or Serum glutamate pyruvate
             transaminase (SGPT) ≤ 2 times normal

          -  Alkaline phosphatase ≤ 2 times normal

        Renal

          -  Serum creatinine ≤ 1.5 mg/dL

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known HIV positivity

          -  No other malignancy within the past 5 years except carcinoma in situ of the cervix or
             nonmelanoma skin cancer

          -  No active infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy or biologic therapy

        Chemotherapy

          -  No prior chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy to the head and neck unless head and neck radiotherapy clearly
             excluded the brain (e.g., localized radiotherapy to the vocal cords)

          -  No prior radiotherapy to the brain

          -  No concurrent intensity modulated radiotherapy

          -  No concurrent stereotactic boost radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  No other concurrent investigational agents