S9804: Vinorelbine in Treating Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003828
First received: November 1, 1999
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003828

  Show 86 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Robert P. Whitehead, MD University of Texas
  More Information

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT00003828     History of Changes
Other Study ID Numbers: CDR0000066983, S9804, U10CA032102
Study First Received: November 1, 1999
Last Updated: August 20, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014