NCT00072124

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as dacarbazine and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Complete metastasectomy may be an effective treatment for metastatic melanoma and may improve quality of life and help patients live longer and more comfortably. It is not yet known whether complete metastasectomy is more effective than chemotherapy in treating stage IV melanoma. PURPOSE: This randomized phase III trial is studying dacarbazine and/or cisplatin to see how well they work compared to complete metastasectomy in treating patients with stage IV melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

June 19, 2013

Status Verified

January 1, 2005

First QC Date

November 4, 2003

Last Update Submit

June 18, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

cisplatinDRUG
dacarbazineDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Solitary pulmonary nodule may not be sole site of metastatic disease * No disease limited to subcutaneous, cutaneous, or peripheral nodal (neck, axillary, groin, or iliac nodes) sites only * Measurable disease * Disease progression during or after prior interleukin-2 (IL-2)-based therapy OR ineligible for high-dose IL-2 therapy * Metastatic disease amenable to complete surgical resection * Less than 5% estimated mortality from surgery * Prior complete metastasectomy allowed provided disease did not recur within 6 months after surgery * No primary ocular or mucosal melanoma * No brain metastases PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * WBC at least 3,000/mm\^3 OR * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No coagulation disorder Hepatic * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance at least 70 mL/min * No major medical illness of the renal system Cardiovascular * No major medical illness of the cardiovascular system Pulmonary * No major medical illness of the respiratory system Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active systemic infection * No form of primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No concurrent palliative radiotherapy Surgery * See Disease Characteristics * No concurrent palliative surgery Other * More than 3 weeks since prior therapy for melanoma (except surgery) * No other concurrent therapy for melanoma

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

CisplatinDacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Richard M. Sherry, MD

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 4, 2003

First Posted

November 6, 2003

Study Start

September 1, 2003

Study Completion

May 1, 2005

Last Updated

June 19, 2013

Record last verified: 2005-01

Locations

US(1)