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Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
This study is ongoing, but not recruiting participants.
First Received: May 6, 2003   Last Updated: July 23, 2008   History of Changes
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: R 115777 Tipifarnib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of R115777 in Patients With Metastatic Malignant Melanoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Biochemical effects [ Designated as safety issue: No ]

Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

  • Determine clinical response in patients with metastatic malignant melanoma treated with tipifarnib.
  • Determine the safety of this drug in these patients.
  • Determine the time to treatment failure in patients treated with this drug.
  • Determine the biochemical effects of this drug on tumor tissue in these patients.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cutaneous melanoma

    • Clinical evidence of distant, metastatic, nonresectable regional lymphatic, or extensive in-transit recurrent disease
  • At least 2 cutaneous lesions amenable to excisional biopsy
  • Measurable disease

    • Disease remaining after the first excisional biopsy must be measurable
    • The following are considered non-measurable disease:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Lesions in a previously irradiated area
  • No history of brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL

Renal

  • Creatinine no greater than 2.0 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No allergy to azole drugs (e.g., ketoconazole)
  • No allergy to compounds of similar structure to tipifarnib

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No more than 1 prior immunotherapy regimen for advanced melanoma

    • One additional adjuvant immunologic regimen (e.g., interferon alfa) allowed
  • More than 4 weeks since prior immunotherapy

Chemotherapy

  • No prior chemotherapy for any stage of melanoma

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No antacids (magnesium- or aluminum-containing formulations) within 2 hours of tipifarnib administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060125

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
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
  More Information

Additional Information:
Publications:
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
Study First Received: May 6, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00060125     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Recurrence
Tipifarnib
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009