NCT00019487

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1998

Typical duration for phase_2

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

November 1, 1998

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

June 20, 2013

Status Verified

March 1, 2003

First QC Date

July 11, 2001

Last Update Submit

June 19, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

aldesleukinBIOLOGICAL
gp209-2M antigenBIOLOGICAL
incomplete Freund's adjuvantBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule * Measurable or evaluable metastatic disease * Must be HLA-A201 positive by standard HLA typing PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Greater than 3 months Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT/AST less than 4 times upper limit of normal Renal: * Creatinine no greater than 1.6 mg/dL Cardiovascular: * For patients randomized to receive interleukin-2: * No major medical illnesses of the cardiovascular system Pulmonary: * For patients randomized to receive interleukin-2: * No major medical illnesses of the pulmonary system Other: * HIV negative * Hepatitis B antigen negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * For patients randomized to receive interleukin-2: * No active systemic infection * No other major medical illnesses of immune system * No coagulation disorders PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * No concurrent steroid therapy Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified Other: * No concurrent active treatment of brain metastases

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, United States

Location

Related Publications (1)

  • Dudley ME, Wunderlich J, Nishimura MI, Yu D, Yang JC, Topalian SL, Schwartzentruber DJ, Hwu P, Marincola FM, Sherry R, Leitman SF, Rosenberg SA. Adoptive transfer of cloned melanoma-reactive T lymphocytes for the treatment of patients with metastatic melanoma. J Immunother. 2001 Jul-Aug;24(4):363-73. doi: 10.1097/00002371-200107000-00012.

    PMID: 11565838BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukinincomplete Freund's adjuvant

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 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

November 1, 1998

Study Completion

May 1, 2003

Last Updated

June 20, 2013

Record last verified: 2003-03

Locations

US(1)