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Tipifarnib in Treating Patients With Metastatic Malignant Melanoma - Article


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Melanoma

Melanoma cancer 



Clinical Trial: Tipifarnib in Treating Patients With Metastatic Malignant Melanoma

This study is currently recruiting patients.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have metastatic malignant melanoma.

Condition Treatment or Intervention Phase
Stage IV Melanoma
Recurrent Melanoma
  Drug: tipifarnib
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
 Phase II

MedlinePlus related topics:  Melanoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Tipifarnib in Patients With Metastatic Malignant Melanoma

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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

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

Location and Contact Information


Alabama
      Northeast Alabama Regional Medical Center, Anniston,  Alabama,  36207,  United States; Recruiting
Thomas W. Twele, MD  256-236-2549 

      Veterans Affairs Medical Center - Birmingham, Birmingham,  Alabama,  35233-1996,  United States; Recruiting
Francisco Robert, MD, FACP  205-933-8101 

California
      Naval Medical Center - San Diego, San Diego,  California,  92134-3202,  United States; Recruiting
Preston Gable, MD  619-532-7303    pgable@nmcsd.med.navy.mil 

      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States; Recruiting
Stephen L. Seagren, MD  619-543-5303 

      Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Alan T. Lefor, MD  310-423-5874    Alan.Lefor@cshs.org 

      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States; Recruiting
Alan Paul Venook, MD  800-888-8664    venook@cc.ucsf.edu 

      Veterans Affairs Medical Center - San Diego, San Diego,  California,  92161,  United States; Recruiting
Saeeda Kirmani, MD  619-552-8585 ext. 3356    skirmani@ucsd.edu 

      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States; Recruiting
Patricia A. Cornett, MD  415-221-4810 ext. 3423    patricia.cornett@med.va.gov 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Edward P. Gelmann, MD  202-444-7303    gelmanne@georgetown.edu 

      Veterans Affairs Medical Center - Washington, DC, Washington,  District of Columbia,  20422,  United States; Recruiting
Steven H. Krasnow, MD  202-745-8178    krasnow.steven@washington.va.gov 

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP  202-782-5762    thomas.reid@na.amedd.army.mil 

Florida
      Broward General Medical Center, Fort Lauderdale,  Florida,  33316,  United States; Recruiting
Luis Ramon Barreras, MD, FACP  954-771-0692 

      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
Rogerio C. Lilenbaum, MD  305-674-2625 

      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States; Recruiting
Jane Crofton, RN, BSN, OCN  407-303-2090 

      Memorial Cancer Institute at Memorial Regional Hospital, Hollywood,  Florida,  33021,  United States; Recruiting
Atif M. Hussein, MD  954-986-6363    ahussein@mhs.net 

      Palm Beach Cancer Institute - West Palm Beach, West Palm Beach,  Florida,  33401,  United States; Recruiting
Robert J. Jacobson, MB, ChB, FACP, FRCP(C)  561-366-4150 

Illinois
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
John W. Kugler, MD  309-243-3605 

      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States; Recruiting
Keith L. Shulman, MD  773-564-5022    KShulman@weisshospital.org 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Karen Wendling  773-834-7424 

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States; Recruiting
Thomas E. Lad, MD  312-996-2046 

      West Suburban Center for Cancer Care, River Forest,  Illinois,  60305,  United States; Recruiting
John L. Showel, MD  708-763-2700    doc.shoj@wsmc.org 

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
Rafat H. Ansari, MD, FACP  574-284-7977 

      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
Sreenivasa Rao Nattam, MD  260-484-8830    ledgar@fwmoh.com 

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Gerald H. Clamon, MD  319-356-8110 

Kentucky
      Baptist Hospital East - Louisville, Louisville,  Kentucky,  40207,  United States; Recruiting
Daniel C. Scullin, MD  502-897-1166 

Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201,  United States; Recruiting
Martin J. Edelman, MD  410-328-2703    medelman@umm.edu 

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
George P. Canellos, MD  617-632-3470    george_canellos@dfci.harvard.edu 

      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01655,  United States; Recruiting
Pankaj Bhargava  508-856-6884    bhargavp@ummhc.org 

Michigan
      Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph,  Michigan,  49085,  United States; Recruiting
Cynthia Bender, BA, CRA  269-985-4516    cbender@lakelandregional.org 

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Bruce A. Peterson, MD  612-624-5631 

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Vicki A. Morrison, MD  612-467-4135    morri002@tc.umn.edu 

Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Michael C. Perry, MD  573-882-4979    perrym@health.missouri.edu 

      Missouri Baptist Cancer Center, Saint Louis,  Missouri,  63131,  United States; Recruiting
Alan Philip Lyss, MD  314-996-5514    alyss@bjc.org 

      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Nancy L. Bartlett, MD  314-362-4843 

      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States; Recruiting
William P. Patterson, MD  573-882-6163 

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
Margaret Anne Kessinger, MD  402-559-7511    makessin@unmc.edu 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
John Allan Ellerton, MD, CM  702-384-0013    k.vanwagenen@sncrf.org 

      Veterans Affairs Medical Center - Las Vegas, Las Vegas,  Nevada,  89106,  United States; Recruiting
Chitha R. Hulugalle, MD  702-696-3000 

New Hampshire
      New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett,  New Hampshire,  03106,  United States; Recruiting
Douglas Jay Weckstein, MD  603-622-6484    d.weckstein@nhoh.com 

      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States; Recruiting
Marc Stuart Ernstoff, MD  603-650-5534    Marc.S.Ernstoff@Hitchcock.org 

New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103,  United States; Recruiting
Edison Catalano, MD  856-342-2506 

New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Vincent P. Vinciguerra, MD  516-562-8954 

      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
Jeffrey J. Kirshner, MD  315-472-7504 

      Elmhurst Hospital Center, Elmhurst,  New York,  11373,  United States; Recruiting
Vladimir Benisovich, MD  718-334-3723    beniso@aol.com 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Clifford A. Hudis, MD  212-639-6483 

      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
Lewis R. Silverman, MD  212-241-5520    lewis.silverman@mssm.edu 

      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
Scott Wadler, MD  212-746-2844    scw2004@med.cornell.edu 

      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Daniel R. Budman, MD  516-562-8958 

      Queens Cancer Center of Queens Hospital, Jamaica,  New York,  11432,  United States; Recruiting
Hans W. Grunwald, MD  718-883-4118    hans.grunwald@mssm.edu 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Ellis G. Levine, MD  716-845-8547 

      SUNY Upstate Medical University Hospital, Syracuse,  New York,  13210,  United States; Recruiting
Stephen L. Graziano, MD  315-464-8200    grazians@upstate.edu 

      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States; Recruiting
Lynn Marie Steinbrenner, MD  716-862-3191    lynn.steinbrenner@med.va.gov 

      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States; Recruiting
Leslie Marion Howard, MD  315-476-7461 ext. 4018    leslie.howard@med.va.gov 

North Carolina
      Cape Fear Valley Medical Center, Fayetteville,  North Carolina,  28302-2000,  United States; Recruiting
Kamal M. Bakri, MD  910-609-6910 

      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

      Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst,  North Carolina,  28374,  United States; Recruiting
Ellen M. Willard, MD  910-295-9205 

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
David Duane Hurd, MD  336-716-2088    dhurd@wfubmc.edu 

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Jeffrey Crawford, MD  919-684-5621    crawf006@mc.duke.edu 

      Lenoir Memorial Cancer Center, Kinston,  North Carolina,  28503-1678,  United States; Recruiting
Peter R. Watson, MD  252-559-2200 ext. 201 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting
Thomas C. Shea, MD  919-966-7746    sheaT@med.unc.edu 

      NorthEast Oncology Associates - Concord, Concord,  North Carolina,  28025,  United States; Recruiting
James Grier Wall, MD  704-783-1370    jwall@northeastmedical.org 

      Veterans Affairs Medical Center - Asheville, Asheville,  North Carolina,  28805-9913,  United States; Recruiting
John C. Lucke, MD  828-299-2540 

      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States; Recruiting
Michael J. Kelley, MD  919-286-0411 ext. 7326 

      Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington,  North Carolina,  28402-9025,  United States; Recruiting
Cyrus A. Kotwall, MD  910-763-4630 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Clara D. Bloomfield, MD  614-293-7518    bloomfield-1@medctr.osu.edu 

Oklahoma
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Howard Ozer, MD, PhD  405-271-4022 

Pennsylvania
      Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States; Recruiting
Richard K. Shadduck, MD  412-578-4355    rshadduck@msn.com 

Rhode Island
      Miriam Hospital at Lifespan, Providence,  Rhode Island,  02906,  United States; Recruiting
William M. Sikov, MD  401-793-7151    wsikov@lifespan.org 

Vermont
      Vermont Cancer Center at University of Vermont, Burlington,  Vermont,  05401-3498,  United States; Recruiting
Hyman Bernard Muss, MD  802-847-3827 

Virginia
      Martha Jefferson Hospital, Charlottesville,  Virginia,  22902,  United States; Recruiting
Stefan M. Gorsch, MD  434-982-8410 

      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States; Recruiting
John D. Roberts, MD  804-828-0450 

      Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke,  Virginia,  24014,  United States; Recruiting
Paul D. Richards, MD  540-982-0237    paul.richards@usoncology.com 

      Virginia Oncology Associates - Norfolk, Norfolk,  Virginia,  23502,  United States; Recruiting
Paul R. Conkling, MD  757-466-8683 

West Virginia
      St. Mary's Medical Center, Huntington,  West Virginia,  25701,  United States; Recruiting
Gerrit A. Kimmey, MD  304-528-4645 

Study chairs or principal investigators

Thomas F. Gajewski, MD, PhD,  Study Chair,  University of Chicago Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000299508; CALGB-500104; NCT00060125
Record last reviewed:  August 2004
Last Updated:  April 5, 2005
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060125
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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