Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma

Inclusion Criteria

• Patients with histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma not otherwise specified (NOS) will be eligible for this protocol; patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a malignant glioma is made
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must have signed an authorization for the release of their protected health information; patients must be registered in the Adult Brain Tumor Consortium (ABTC) Central Office database prior to treatment with study drug
• Patients must have a life expectancy > 8 weeks
• Patients must have a Karnofsky performance status of >= 60
• Patients must have recovered from the toxic effects of prior therapy: 4 weeks (28 days) from any investigational agent, 4 weeks (28 days) from prior cytotoxic therapy, two weeks (14 days) from vincristine, 6 weeks (42 days) from nitrosoureas, 3 weeks (21 days) from procarbazine administration, and 1 week (7 days) for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the study chair
• WBC >= 2,000/ul
• ANC >= 1,500/mm^3
• Platelet count of >= 100,000/mm^3
• Hemoglobin >= 10 gm/dl
• Total bilirubin within normal institutional limits
• AST (SGOT)/ALT (SGPT) =< 2.5 X institutional ULN
• Creatinine < 1.5 mg/dL
• Patients must have cholesterol level =< 350 mg/dl and triglycerides level =< 400 mg/dl
• Patients must have shown unequivocal evidence for tumor progression by MRI or CT scan; a scan should be performed within 14 days prior to registration; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement
• Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 6 weeks (42 days) from the completion of radiation therapy to study entry
• Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium scanning, MR spectroscopy or surgical documentation of disease
• 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 tumor is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable or decreasing steroid dosage for at least 5 days
• PHASE I: Patients may have had treatment for any number of prior relapses; relapse is defined as progression following initial therapy (i.e. radiation+/- chemo if that was used as initial therapy)
• PHASE I: For the baseline MRI or CT scan prior to registration, patients in the Phase I component should be on a steroid dose that has been stable for at least 5 days prior to the scan; if the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required
• PHASE II: Patients may have had treatment for no more than 2 prior relapses; relapse is defined as progression following initial therapy (i.e. radiation+/- chemo if that was used as initial