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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085566 |
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).
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Prostate Cancer |
Drug: everolimus Drug: gefitinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | 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 |
Estimated Enrollment: | 58 |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, open-label, non-randomized, dose-escalation study of everolimus followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion of this study within 6 months. A total of 27-40 patients will be accrued for the phase II portion of this study within 8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Glioblastoma multiforme (GBM) (phase I only)
Progressive disease based on 1 of the following:
Castrate metastatic prostate cancer (closed to accrual as of 10/19/2006) (phase I and II)
Progressive disease based on 1 or more of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No other active malignancy except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Spain | |
Vall d'Hebron University Hospital | |
Barcelona, Spain, 08035 |
Principal Investigator: | Howard I. Scher, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Neal Rosen, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Lauren E. Abrey, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000370826, MSKCC-04010 |
Study First Received: | June 10, 2004 |
Last Updated: | June 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00085566 |
Health Authority: | United States: Federal Government |
adult glioblastoma recurrent prostate cancer recurrent adult brain tumor |
stage IV prostate cancer adult giant cell glioblastoma adult gliosarcoma |
Everolimus Glioblastoma Prostatic Diseases Astrocytoma Genital Neoplasms, Male Urogenital Neoplasms Central Nervous System Neoplasms Genital Diseases, Male Recurrence Brain Neoplasms |
Neuroectodermal Tumors Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Gefitinib Prostatic Neoplasms Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Neuroepithelial |