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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060125 |
Purpose
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 |
|
Melanoma (Skin) |
Drug: tipifarnib |
Phase II |
| MedlinePlus related topics: | Cancer Melanoma |
| Drug Information available for: | Tipifarnib |
| 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.
Eligibility
| 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
Contacts and Locations| 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 | |||||
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Gajewski TF, Niedzwiecki D, Johnson J, et al.: Phase II study of the farnesyltransferase inhibitor R115777 in advanced melanoma: CALGB 500104. [Abstract] J Clin Oncol 24 (Suppl 18): A-8014, 456s, 2006.
  |
| Study ID Numbers: | CDR0000299508, CALGB-500104 |
| First Received: | May 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060125 |
| Health Authority: | United States: Federal Government |
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