Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy
Phase 2
N/A
N/A
N/A
N/A
Not Enrolling
Both
Melanoma (Skin)
Both
Melanoma (Skin)
Trial Information
Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy
OBJECTIVES: I. Evaluate the response rate (complete or partial) of patients with
disseminated stage IV melanoma treated with vinorelbine. II. Assess the qualitative and
quantitative toxic effects of vinorelbine in these patients.
OUTLINE: Patients receive vinorelbine by IV over 6 to 10 minutes weekly. Treatment continues
in the absence of disease progression, unacceptable toxicity, or complete response to
therapy. Patients are followed every 3 months for 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, pathologically verified, disseminated
stage IV melanoma that is surgically incurable Any T, any N, M1a or M1b Must have received
at least one prior chemotherapy, biologic/immunotherapy, or combination regimen for
metastatic disease At least 4 weeks since prior systemic therapy Bidimensionally
measurable disease by physical exam, CT scan, radionuclide scan, or plain x-ray outside
previously irradiated area No brain metastases by MRI or CT scan (except completely
resected brain tumors that have undergone whole brain radiotherapy)
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: HIV negative Not pregnant or nursing Fertile patients must use effective
contraception No other prior malignancy within the past 5 years, except: Adequately
treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer
Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks
since prior adjuvant biologic or immunotherapy Chemotherapy: See Disease Characteristics
No prior adjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Robert P. Whitehead, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas
Authority:
United States: Federal Government
Study ID:
CDR0000066983
NCT ID:
NCT00003828
Start Date:
May 1999
Completion Date:
March 2004
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| MBCCOP - University of South Alabama | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Texas Tech University Health Science Center | Lubbock, Texas 79415 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
| Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
| University of New Mexico Cancer Research & Treatment Center | Albuquerque, New Mexico 87131 |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
| Louisiana State University Hospital - Shreveport | Shreveport, Louisiana 71130-3932 |
