Skin Carcinoma, Merkel Cell |
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Clinical Trial: Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Imatinib mesylate 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 imatinib mesylate in treating patients who have metastatic or unresectable Merkel cell cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage III Merkel cell carcinoma recurrent Merkel cell carcinoma stage II Merkel cell carcinoma | Drug: imatinib mesylate Procedure: enzyme inhibitor therapy Procedure: protein tyrosine kinase inhibitor therapy | Phase II |
MedlinePlus related topics: Skin Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Imatinib Mesylate in Patients With Metastatic or Unresectable Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
OBJECTIVES:
- Determine the feasibility of imatinib mesylate in patients with metastatic or unresectable Merkel cell carcinoma.
- Determine the objective response probability (confirmed and unconfirmed complete and partial responses) in patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or symptomatic deterioration.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed neuroendocrine carcinoma of the skin (Merkel cell carcinoma) with all of the following characteristics:
- Distantly metastatic or unresectable disease
- Primary site must be of skin origin
- No unknown primary
- c-kit (CD117) expression by immunohistochemical staining
- Measurable disease
- Patients whose only disease is within a previous radiation port must demonstrate clearly progressive disease
- No symptomatic, unstable, or previously untreated brain metastases
- Prior treatment must be completed at least 28 days before study entry
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (transfusion allowed)
Hepatic
- Bilirubin no greater than 3 times upper limit of normal (ULN) (including presence of liver metastasis)
- SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastasis is present)
- No uncontrolled chronic liver disease
Renal
- Creatinine no greater than 1.5 times ULN
- No uncontrolled chronic renal disease
Cardiovascular
- No New York Heart Association class III or IV cardiac problems
- No myocardial infarction within the past 2 months
- No congestive heart failure
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- HIV negative
- No uncontrolled diabetes
- No active uncontrolled infection
- No other concurrent severe and/or uncontrolled medical illness
- No medical or psychological condition that would preclude study treatment or compliance
- No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy
- More than 28 days since prior biologic therapy
- No concurrent anticancer biologic therapy
Chemotherapy
- More than 28 days since prior chemotherapy
- No concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 28 days since prior radiotherapy
- No concurrent radiotherapy
Surgery
- More than 14 days since prior major surgery (e.g., large chest and abdominal incisions or major soft tissue resections)
Other
- Recovered from prior therapy
- More than 28 days since prior investigational drugs
- Concurrent heparin for therapeutic anticoagulation allowed
- Concurrent mini-dose warfarin (1 mg/day) for central venous catheter thrombosis prophylaxis allowed
- No concurrent therapeutic warfarin
- No other concurrent investigational drugs
- No other concurrent anticancer agents
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5216, United States; Recruiting
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, 33612-9497, United States; Recruiting
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States; Recruiting
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Kansas
Cancer Center of Kansas - Liberal, Liberal, Kansas, 67901, United States; Recruiting
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Louisiana
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Maryland
Johns Hopkins at Green Spring Station, Lutherville, Maryland, 21093, United States; Recruiting
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Minnesota
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
CCOP - Northern New Jersey, Hackensack, New Jersey, 07601, United States; Recruiting
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, 10466, United States; Recruiting
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
CCOP - MainLine Health, Wynnewood, Pennsylvania, 19096, United States; Recruiting
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111-2497, United States; Recruiting
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15236, United States; Recruiting
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-6307, United States; Recruiting
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226-3596, United States; Recruiting
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-0001, United States; Recruiting
Australia, New South Wales
Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney, New South Wales, 2050, Australia; Recruiting
Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting
Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Puerto Rico
MBCCOP - San Juan, San Juan, 00921-3201, Puerto Rico; Recruiting
South Africa
Pretoria Academic Hospital, Pretoria, 0001, South Africa; Recruiting
Wolfram Samlowski, MD, University of Utah
Michael C. Heinrich, MD, Oregon Health and Science University
Naomi S. Balzer-Haas, MD, Study Chair, Fox Chase Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2004
Last Updated: April 5, 2005
Record first received: September 10, 2003
ClinicalTrials.gov Identifier: NCT00068783
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Basal Cell Carcinoma, see Skin Cancer (National Cancer Institute)

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