| Inclusion Criteria: | Does pt have histologically proven supratentorial malignant primary gliomas to be eligible? These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO) and mixed malignant gliomas (MMG).
Does the pt have measurable lesions with clearly defined margins or MRI scan performed within 14 days prior to registration?
Is the patient >/= 18 years of age?
Does the patient have a Karnofsky >/= 60%?
Does the patient have a 1-3wks interval between prior resection and enrollment to the study?
Does the patient have a 4-wks interval between prior radiation therapy and enrollment to the study?
Have all acute toxic effects (excluding neurotoxicity or alopecia) of any prior therapy resolved to CTC grade </= 1?
If the steroid dose increased between the date of imaging and the initiation of Temozolomide (Temodar) and CPT-11 (or at that time), does the patient have a new MRI scan?
If the patient has undergone recent resection for recurrent or progressive tumor, has the patient recovered from the effect of surgery?
If the patient has undergone recent resection, has the patient had a post surgery MRI scan within 48 - 96 hours, or a MRI scan 4 - 6 weeks after surgery?
Does the patient have adequate renal function defined as serum creatinine </=1.5 mg/dL within 14 days prior to registration?
Has the patient signed an informed consent?
Is the patient willing & able to comply with scheduled visits, treatment plan & lab tests?
If the patient is taking valproic acid, is he/she also receiving another EIAED?
Is the patient willing to practice birth control?
Ph I (Group B): patients may have had three prior relapses.
Ph II (Group A or B): patients may have had no more than two prior relapses.
Pts with prior therapy that include interstitial brachytherapy or stereotactic radiosurgery have confirm of true progress. disease rather than radiation necrosis based upon either PET or Thallium scanning, MR spectroscopy or surgical docum of disease
Pts should have adequate bone marrow function, defined as a WBC >/= 3000/ul, ANC >/= 1500/mm3, platelet count of >/= 100,000/mm3, and hemoglobin >/= 10 gm%
Pt also elig. if the original histology was low grade glioma & a subseq. histological diagn. of a malign. glioma is made.
Does the patient have adequate liver function as documented by a serum total bilirubin </= 1.5 mg/dL. SGOT must be </= 2 times the institutional ULN within 14 days prior to registration?
The patient must have signed an Authorization for the release of their protected health information.
Does pt. have measurable recurrent or residual primary CNS neoplasm on MRI scan performed on a steroid dose that has been stable or decreasing for at least 5-7 days and w/in 14 days prior to initiation of Temozolomide & CPT-11.
Pt. recovered from toxic effect of prior therapy: 4 wks from investigational agents, 4 wks from prior cytotoxic therapy and/or at least 2 wks from vincristine, 6 wks from nitosoureas, 3 wks from procarbazine admin & 1 wk for non-cytotoxic agents.
Pt must shown unequivocal evid of tumor recur/prog by MRI or CT. Scan done w/in 14d prior to start of Temozolomide & CPT11 & on steroid dosage stable for 5-7d. If steroid dose incr between scan and CPT new baseline required. |