Clinical trial NCT00085566 (phase 1/phase 2, status: completed)
Conditions: brain and central nervous system tumors, prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: everolimus, gefitinib
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1
Eligibility criteria:

        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