| Inclusion Criteria: | Histological proven recurrent supratentorial malig primary glioma, brain or spinal meningioma; including GBM, AA, AO, AMO, MA(NOS), benign or malig meningiomas.
Phase I/II: Low grade original histology with subsequent diagnosis of malig glioma.
Recent resection pts have recovered from effects of surgery (at least 7 days since date of surgery).
Pts with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease determined by PET or Thallium scanning, MR spectroscopy or surgical documentation of disease.
Signed informed consent.
Age >/= 18 yrs and life expectancy > 8 wks.
Karnofsky performance status of >/= 60.
All pts of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.
Baseline ophthalmologic exam, including slit lamp exam by an ophthalmologist.
Pt has provided the drug names for all prior therapy.
Adequate renal function: Serum creatinine<1.5mg/dL or creatinine clearance>/=60cc/min) within 14 days of registration.
All Phase I/II except recent surgery pts: Unequivocal evidence for tumor progression by MRI/CT scan performed prior to registration.
All Phase I/II except pre-op: Baseline MRI/CT within 14 days prior to registration and on steroid dose that has been stable for at least 5 days.
All Phase I/II except pre-op pts: For steroid doses increased between date of imaging & registration, new baseline MRI/CT needs to be performed on at least 5 days of stable steroids.
Recent resection pts need post-op MRI/CT within 96 hrs or at least 4 wks after surgery.
Recent resection pts: If 96h scan > 14 days prior to registration repeat scan on 5 days of decreasing or stable steroids.
Pt recovered from toxic effects of prior therapy: 4 wks from investigational agents, 4 wks from cytotoxic therapy, 2 wks from vincristine, 6 wks from nitrosureas, 3 wks from procarbazine, 1 wk from non-cytotoxic agents.
Adequate bone marrow function: WBC>/=3000uL,ANC>/=1500/mm3, platelets>/=120,000/mm3,Hgb>/=10gm/dl; & adequate liver function: SGOT & Bilirubin <1.5xULN, all within 14 days of registration.
Negative pregnancy test within 14 days prior to registration.
Phase I/II: Patients with radiographically defined or histologically proven, recurrent/progressive meningioma will be eligible for this protocol.
Phase I/II: Patients with hemangiopericytoma will also be eligible.
Phase I/II: Glioma pts who have failed prior radiation therapy with an interval of 4 wks or greater from completion to study entry.
Phase I Glioma pts must have had treatment for no more than 3 prior relapses.
Phase II Glioma pts must have had treatment for no more than 2 prior relapses.
There is no limitation on the number of prior surgeries, radiation therapy, radiosurgery treatments or chemotherapy for the Meningioma or Hemangiopericytoma patients.
Prior radiation therapy is not mandated in Meningioma or Hemangiopericytoma patients.
Meningioma or Hemangiopericytoma patients may have had treatment with radiation, which could include standard external beam radiation, interstitial brachytherapy or gamma-knife radiosurgery in any combination.
If radiation therapy was used for the Meningioma or Hemangiopericytoma pts, there must be an interval of =/> 4 wks from completion of radiation therapy to study entry and must be subsequent evidence of tumor progression documented.
Pts. receiving low molecular weight Heparinoids or Coumadin for DVT or Pulmonary Embolis may be entered into the trial.
Has the patient signed an Authorization for the release of protected health information? |