Clinical trialNCT00019682CompletedPhase 3Interventional

Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma

SponsorNational Cancer Institute (NCI)Enrollment185Recurrent MelanomaStage IIIA Skin MelanomaStage IIIB Skin MelanomaStage IIIC Skin MelanomaStage IV Skin Melanoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Douglas Schwartzentruber
IU Health Goshen Center for Cancer Care
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Kaiser Permanente Medical Center
Riverside, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Emory University/winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Lutheran General Hospital.
Park Ridge, Illinois, United States
Iu Health Goshen Center for Cancer Care
Goshen, Indiana, United States
the James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
National Institutes of Health
Bethesda, Maryland, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
the Christ Hospital
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Saint Luke'S University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
Aurora Saint Luke'S Medical Center
Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Aldesleukin →Incomplete Freund's adjuvantGP-100 antigen

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 1999
Primary completion: 31 May 2011
Completion: 31 May 2011
Last update posted: 20 Nov 2017
Registered enrollment: 185
Registry id: NCT00019682

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.