NCT00019175

Brief Summary

RATIONALE: Vaccines made from an antigen combined with a modified virus may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase I trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have recurrent metastatic melanoma that has not responded to previous therapy.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

May 26, 2003

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2003

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

aldesleukinBIOLOGICAL
fowlpox virus vaccine vectorBIOLOGICAL
gp100 antigenBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma that has failed standard therapy Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 8.0 g/dL No coagulation disorder Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT less than 4 times normal Hepatitis B negative Renal: Creatinine no greater than 1.6 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major respiratory disease Other: HIV negative No other major immunologic illness No eczema No hypersensitivity to eggs No active systemic infection No psoriasis Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 20 days since prior therapy No concurrent steroid therapy

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

Sponsors & Collaborators

Study Sites (1)

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin

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

Study Officials

  • Steven A. Rosenberg, MD, PhD

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

May 26, 2003

Study Start

August 1, 1996

Last Updated

April 29, 2015

Record last verified: 2003-04

Locations

US(1)