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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060125 |
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying how well tipifarnib works in treating patients with metastatic malignant melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: tipifarnib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of R115777 in Patients With Metastatic Malignant Melanoma |
Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.
Patients who discontinue therapy due to toxicity or complete response are followed every 3 months for 2 years after study entry. Patients who discontinue therapy due to disease progression are followed every 6 months for 2 years after study entry. Patients with stable or partially responding disease who complete treatment are followed at 2 years after study entry.
PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cutaneous melanoma
Measurable disease
The following are considered non-measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No more than 1 prior immunotherapy regimen for advanced melanoma
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, District of Columbia | |
Lombardi Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Florida Hospital - Orlando | |
Orlando, Florida, United States, 32803 | |
United States, Georgia | |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
Savannah, Georgia, United States, 31403 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Incorporated | |
Fort Wayne, Indiana, United States, 46815 | |
United States, Iowa | |
Iowa Blood and Cancer Care | |
Cedar Rapids, Iowa, United States, 52402 | |
Mercy Cancer Center at Mercy Medical Center | |
Cedar Rapids, Iowa, United States, 52403 | |
St. Luke's Hospital | |
Cedar Rapids, Iowa, United States, 52402 | |
United States, Missouri | |
Capital Region Cancer Center | |
Jefferson City, Missouri, United States, 65101 | |
Ellis Fischel Cancer Center at University of Missouri - Columbia | |
Columbia, Missouri, United States, 65203 | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
St Louis, Missouri, United States, 63110 | |
United States, New York | |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
Syracuse, New York, United States, 13057 | |
Community General Hospital of Greater Syracuse | |
Syracuse, New York, United States, 13215 | |
Faxton Regional Cancer Center | |
Utica, New York, United States, 13502 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Presbyterian Cancer Center at Presbyterian Hospital | |
Charlotte, North Carolina, United States, 28233 | |
Wayne Memorial Hospital, Incorporated | |
Goldsboro, North Carolina, United States, 27534 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Rhode Island | |
Memorial Hospital of Rhode Island | |
Pawtucket, Rhode Island, United States, 02860 | |
United States, Tennessee | |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | |
Kingsport, Tennessee, United States, 37660 |
Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
Study ID Numbers: | CDR0000299508, CALGB-500104 |
Study First Received: | May 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00060125 History of Changes |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Nevus |
Recurrence Tipifarnib Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Pharmacologic Actions Tipifarnib Neuroendocrine Tumors Melanoma |