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S9804: Vinorelbine in Treating Patients With Stage IV Melanoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: November 1, 1999
Last updated: August 20, 2012
Last verified: August 2012

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 Intervention Phase
Melanoma (Skin) Drug: vinorelbine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Enrollment: 24
Study Start Date: May 1999
Study Completion Date: March 2004
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vinorelbine
vinorelbine 30 mg/m2/week IV bolus over approximately 6-10 minutes
Drug: vinorelbine
Other Name: navelbine

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.


Ages Eligible for Study:   Child, Adult, Senior
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

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Please refer to this study by its identifier: NCT00003828

  Show 86 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert P. Whitehead, MD University of Texas
  More Information

Moon J, Whitehead RP, McCachren S, et al.: Evaluation of vinorelbine tartrate (Navelbine) in patients with dissemminated malignant melanoma and at least one prior systemic therapy, phase II: a Southwest Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1386, 2002.

Responsible Party: Southwest Oncology Group Identifier: NCT00003828     History of Changes
Other Study ID Numbers: CDR0000066983
S9804 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Study First Received: November 1, 1999
Last Updated: August 20, 2012

Keywords provided by Southwest Oncology Group:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017