A Phase I/II Trial to Assess the Tolerability of RAD 001 With Gefitinib in Patients With Glioblastoma Multiforme and Prostate Cancer and Efficacy in Patients With Castrate Metastatic Prostate Cancer

Study start date: March 1, 2004

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Glioblastoma multiforme (GBM) (phase I only) * Progressive disease despite standard therapy * Progressive disease based on 1 of the following: * New or progressive (25% bidimensional increase) soft tissue masses on CT scan or MRI * New or prior lesions that have increased in size by physical examination * Patients who had prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true disease progression (rather than radiation necrosis) by positron-emission tomography scan, thallium scanning, magnetic resonance spectroscopy, or surgical documentation * Castrate metastatic prostate cancer (closed to accrual as of 10/19/2006) (phase I and II) * Progressive disease despite standard therapy AND castrate levels \< 50 ng/dL of testosterone * Progressive disease based on 1 or more of the following: * A minimum of 3 rising levels of prostate-specific antigen (PSA) that are obtained 1 or more weeks apart OR 2 rising PSA values obtained more than 1 month apart with at least a 25% increase over the range of values * New or progressive (25% bidimensional increase) soft tissue masses on CT scan or MRI * New metastatic lesions * Patients on an antiandrogen as part of initial therapy must show disease progression after discontinuation of the antiandrogen * Patients who have not undergone surgical orchiectomy must continue with medical therapy (e.g., gonadotropin-releasing hormone analogs) to maintain castrate levels of serum testosterone * No brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * ALT and AST ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine within 1.5 times ULN (\< 1.95 mg/dL at MSKCC) Cardiovascular * No significant cardiovascular disease * No congestive heart failure * No New York Heart Association class III or IV cardiac disease * No active angina pectoris * No myocardial infarction within the past 6 months Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No serious medical illness * No severe infection * No severe malnutrition * No other active malignancy except non-melanoma skin cancer * Patients are not considered to have an active malignancy if they have completed prior therapy and currently have a \< 30% risk for relapse PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biological therapy * No concurrent immunotherapy Chemotherapy * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * Prior recent resection of recurrent or progressive GBM allowed provided patient has recovered * More than 4 weeks since prior major surgery Other * Recovered from all prior therapy * More than 4 weeks since prior investigational anticancer drugs * No concurrent anticonvulsant that interacts with CYP3A4 (e.g., phenytoin, carbamazepine, or phenobarbital) * No other concurrent cytotoxic therapy * No other concurrent investigational or commercial agents or therapies for the malignancy