VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma

DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically proven malignant glioma including any of the following:

  * Glioblastoma multiforme
  * Gliosarcoma
  * Anaplastic astrocytoma
  * Anaplastic oligodendroglioma
  * Anaplastic mixed oligoastrocytoma
  * Malignant astrocytoma not otherwise specified
* Unequivocal evidence of tumor recurrence or progression by MRI or CT scan with contrast
* No more than one relapse
* Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:

  * More than 2 weeks from surgery and have recovered from the effects of surgery
  * Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study if a treatment failure can be evaluated
  * Enhanced CT scan/ MRI should be done no later than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively

    * If the 96-hour scan is more than 2 weeks from registration, the scan needs to be repeated
    * A baseline scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for 5 or more days otherwise a new baseline MRI/CT is required
    * The same type of scan (i.e., MRI or CT scan) must be used throughout the period of protocol treatment for tumor measurement
* Must have failed prior external-beam radiotherapy
* Must have failed one prior systemic treatment with chemotherapy or biologic agents

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Karnofsky performance status 60-100%
* Life expectancy \> 12 weeks
* WBC \> 3,000/mm³
* ANC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 10 mg/dL
* AST and ALT \< 4 times upper limit of normal (ULN)
* Bilirubin \< 2 times ULN
* Creatinine \< 1.5 times ULN
* Fertile patients must use acceptable contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device)
* Negative pregnancy test
* Not pregnant or nursing

Exclusion criteria:

* Active uncontrolled bleeding
* Active infection of any kind
* Unwilling or unable to follow protocol requirements or to give informed consent
* Active heart disease including any of the following:

  * Myocardial infarction within the past 3 months
  * Uncontrolled arrhythmias
  * Uncontrolled coronary artery disease
  * Uncontrolled congestive heart failure
* Known HIV-positive patients (HIV testing is not required)
* History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* See Disease Characteristics
* Recovered from prior therapy
* At least 2 weeks since prior vincristine
* More than 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)
* More than 4 weeks since prior radiotherapy
* More than 4 weeks since prior experimental biologic agents (e.g., EGFR inhibitors, etc)
* More than 3 weeks since prior procarbazine administration
* More than 2 weeks since prior non-cytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin)

  * Radiosensitizer does not count
* At least 2 weeks since prior and no concurrent enzyme inducing anticonvulsants

  * If patient is on an enzyme inducing anticonvulsant, they may be converted to a non-enzyme inducing anticonvulsant

Exclusion criteria:

* Any other concurrent standard or investigational treatment for cancer, or any other investigational agent for any indication
* Concurrent disulfiram