Temozolomide in Treating Patients With Low-Grade Glioma
Condition: CNS Tumor, Adult
MeSH terms: Glioma; Central Nervous System Neoplasms
Intervention: temozolomide
Intervention description: Chemotherapy
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult oligodendroglioma; adult mixed glioma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult pineal gland astrocytoma

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.

      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients
      with supratentorial low-grade glioma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven supratentorial low-grade (grade II) glioma of any of the
             following histologic subtypes:

               -  Oligodendroglioma

               -  Astrocytoma

               -  Oligoastrocytoma

          -  Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade
             glioma

               -  Study treatment must begin between 14 days and 4 months after surgical resection
                  or biopsy

          -  Evaluable disease by gadolinium-MRI

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 60-100%

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL

          -  Creatinine < 1.5 times upper limit of normal (ULN)

          -  BUN < 1.5 times ULN

          -  Bilirubin < 1.5 times ULN

          -  SGOT < 2.5 times ULN

          -  Alkaline phosphatase < 2 times ULN

          -  Life expectancy > 12 weeks

          -  No nonmalignant systemic disease resulting in the patient being a poor medical risk

          -  No acute infection requiring intravenous antibiotics

          -  No frequent vomiting or medical condition that would interfere with oral medication
             intake (e.g., partial bowel obstruction)

          -  No other concurrent malignancies except surgically cured carcinoma in situ of the
             cervix or basal cell or squamous cell carcinoma of the skin

               -  Prior malignancies must be in remission for ≥ 5 years

          -  No known HIV positivity

          -  No AIDS-related illness

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade
             glioma

          -  No prior biological therapy or chemotherapy for low-grade glioma

          -  No other concurrent chemotherapy

          -  No concurrent radiotherapy or biological therapy

          -  No concurrent prophylactic growth factors

          -  No concurrent epoetin alfa

          -  No other concurrent investigational drugs