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S9804: Vinorelbine in Treating Patients With Stage IV Melanoma

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003828
Collaborator
National Cancer Institute (NCI) (NIH)
24
Enrollment
86
Locations
1
Arm
58
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy
Study Start Date :
May 1, 1999
Actual Primary Completion Date :
Dec 1, 2001
Actual Study Completion Date :
Mar 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: vinorelbine

vinorelbine 30 mg/m2/week IV bolus over approximately 6-10 minutes

Drug: vinorelbine
Other Names:
  • navelbine

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 MBCCOP - University of South Alabama Mobile Alabama United States 36688
      2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
      3 Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona United States 85012
      4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
      5 Arizona Cancer Center Tucson Arizona United States 85724
      6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
      7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
      8 Beckman Research Institute, City of Hope Duarte California United States 91010
      9 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
      10 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033-0800
      11 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
      12 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
      13 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
      14 Chao Family Comprehensive Cancer Center Orange California United States 92868
      15 University of California Davis Medical Center Sacramento California United States 95817
      16 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94115-0128
      17 Veterans Affairs Medical Center - San Francisco San Francisco California United States 94121
      18 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
      19 David Grant Medical Center Travis Air Force Base California United States 94535
      20 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
      21 University of Colorado Cancer Center Denver Colorado United States 80262
      22 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
      23 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
      24 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
      25 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
      26 Loyola University Medical Center Maywood Illinois United States 60153
      27 CCOP - Central Illinois Springfield Illinois United States 62526
      28 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
      29 CCOP - Wichita Wichita Kansas United States 67214-3882
      30 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
      31 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
      32 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
      33 MBCCOP - LSU Medical Center New Orleans Louisiana United States 70112
      34 Tulane University School of Medicine New Orleans Louisiana United States 70112
      35 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
      36 Louisiana State University Hospital - Shreveport Shreveport Louisiana United States 71130-3932
      37 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
      38 Boston Medical Center Boston Massachusetts United States 02118
      39 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
      40 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
      41 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
      42 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
      43 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
      44 Henry Ford Hospital Detroit Michigan United States 48202
      45 CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
      46 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
      47 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
      48 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
      49 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
      50 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
      51 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
      52 CCOP - Kansas City Kansas City Missouri United States 64131
      53 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
      54 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
      55 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
      56 CCOP - Montana Cancer Consortium Billings Montana United States 59101
      57 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
      58 University of New Mexico Cancer Research & Treatment Center Albuquerque New Mexico United States 87131
      59 Veterans Affairs Medical Center - Brooklyn Brooklyn New York United States 11209
      60 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
      61 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
      62 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
      63 Cleveland Clinic Cancer Center Cleveland Ohio United States 44195
      64 CCOP - Columbus Columbus Ohio United States 43206
      65 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
      66 CCOP - Dayton Kettering Ohio United States 45429
      67 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
      68 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
      69 Oregon Cancer Center at Oregon Health Sciences University Portland Oregon United States 97201-3098
      70 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
      71 CCOP - Columbia River Program Portland Oregon United States 97213
      72 CCOP - Greenville Greenville South Carolina United States 29615
      73 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
      74 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
      75 University of Texas Medical Branch Galveston Texas United States 77555-1329
      76 Texas Tech University Health Science Center Lubbock Texas United States 79423
      77 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284
      78 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
      79 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
      80 CCOP - Scott and White Hospital Temple Texas United States 76508
      81 Huntsman Cancer Institute Salt Lake City Utah United States 84132
      82 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
      83 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
      84 Swedish Cancer Institute Seattle Washington United States 98104
      85 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
      86 CCOP - Northwest Tacoma Washington United States 98405-0986

      Sponsors and Collaborators

      • Southwest Oncology Group
      • National Cancer Institute (NCI)

      Investigators

      • Study Chair: Robert P. Whitehead, MD, University of Texas

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Southwest Oncology Group
      ClinicalTrials.gov Identifier:
      NCT00003828
      Other Study ID Numbers:
      • CDR0000066983
      • S9804
      • U10CA032102
      First Posted:
      Aug 4, 2004
      Last Update Posted:
      Aug 22, 2012
      Last Verified:
      Aug 1, 2012
      Keywords provided by Southwest Oncology Group
      stage IV melanoma
      recurrent melanoma
      Additional relevant MeSH terms:
      Melanoma
      Vinorelbine

      Study Results

      No Results Posted as of Aug 22, 2012