S9804: Vinorelbine in Treating Patients With Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00003828|
Recruitment Status : Completed
First Posted : August 4, 2004
Last Update Posted : August 22, 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 or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: vinorelbine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy|
|Study Start Date :||May 1999|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||March 2004|
vinorelbine 30 mg/m2/week IV bolus over approximately 6-10 minutes
Other Name: navelbine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003828
Show 86 Study Locations
|Study Chair:||Robert P. Whitehead, MD||University of Texas|