Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by stopping blood flow to the tumor. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining everolimus with gefitinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with gefitinib and to see how well they work in treating patients with progressive glioblastoma multiforme or (progressive metastatic prostate cancer closed to accrual 10/19/06).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Gefitinib; Sirolimus

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