Temozolomide in Treating Patients With Recurrent High-Grade Glioma
Condition: Recurrent Central Nervous System Neoplasm
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms; Recurrence
Intervention: temozolomide
Intervention description: single arm study
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; recurrent adult brain tumor

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 recurrent high-grade glioma.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients with radiographically proven recurrent, intracranial malignant glioma will be
             eligible for this protocol.

          -  All patients must sign an informed consent

          -  Patients must have had external beam radiation; there is no limit to the number of
             prior chemotherapies used.

          -  Patients must be > 18 years old, and with a life expectancy > 8 weeks.

          -  Patients must have a Karnofsky performance status of > 60.

          -  At the time of registration: Patients must have recovered from the toxic effects of
             prior therapy:

          -  Patients must have adequate bone marrow function.

          -  Patients must have shown unequivocal radiographic evidence for tumor progression by
             MRI

          -  Patients having undergone recent resection of recurrent or progressive tumor will be
             eligible as long as all of the following conditions apply: They have recovered from
             the effects of surgery. Residual disease following resection of recurrent intracranial
             malignant glioma is not mandated for eligibility into the study.

          -  Patients must have failed prior radiation therapy and must have an interval of greater
             than or equal to 42 days from the completion of radiation therapy to study entry.

          -  Patients with prior therapy that included interstitial brachytherapy, stereotactic
             radiosurgery, or Gliadel wafers must have confirmation of true progressive disease
             rather than radiation necrosis based upon either PET or MR spectroscopy or surgical
             documentation of disease.

          -  Male and female patients with reproductive potential must use an approved
             contraceptive method

        Exclusion Criteria

          -  Patients must not have any significant medical illnesses that in the investigator's
             opinion cannot be adequately controlled with appropriate therapy or would compromise
             the patient's ability to tolerate this therapy

          -  Patients with a history of any other cancer (except non-melanoma skin cancer or
             carcinoma in-situ of the cervix), unless in complete remission and off of all therapy
             for that disease for a minimum of 3 years are ineligible.

          -  Patients must not have active infection or serious intercurrent medical illness.

          -  Patients must not be pregnant/breast feeding and must agree to practice adequate
             contraception.