NCT00019669

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Longer than P75 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

October 1, 1999

Completed
1.8 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
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 20, 2013

Status Verified

August 1, 2004

First QC Date

July 11, 2001

Last Update Submit

June 19, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

aldesleukinBIOLOGICAL
fowlpox virus vaccine vectorBIOLOGICAL
gp100 antigenBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven metastatic melanoma that has failed standard treatment * Measurable disease * HLA-A-201 positive PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 90,000/mm\^3 * No coagulation disorders Hepatic: * Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * AST/ALT \< 2 times normal * Hepatitis B surface antigen negative Renal: * Creatinine ≤ 2.0 mg/dL Cardiovascular: * No major cardiovascular disease * No cardiac ischemia by a stress thallium test or other comparable test\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \*In order to be eligible to receive interleukin-2 (IL-2) Pulmonary: * No major respiratory disease * No obstructive or restrictive pulmonary disease\* NOTE: \*In order to be eligible to receive IL-2 Immunologic: * No autoimmune disease * No known immunodeficiency disease * No primary or secondary immunodeficiency * No allergy to eggs * No active systemic infections * HIV negative Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other active major medical illness\* NOTE: \*In order to be eligible to receive IL-2 PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior gp100 vaccination Chemotherapy: * Not specified Endocrine therapy: * No concurrent steroids Radiotherapy: * Not specified Surgery: * Prior surgery for the malignancy allowed Other: * At least 3 weeks since other prior therapy for the malignancy

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

Related Publications (1)

  • Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Topalian SL, Sherry RM, Restifo NP, Wunderlich JR, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, Gritz L, Panicali DL, White DE. Recombinant fowlpox viruses encoding the anchor-modified gp100 melanoma antigen can generate antitumor immune responses in patients with metastatic melanoma. Clin Cancer Res. 2003 Aug 1;9(8):2973-80.

    PMID: 12912944BACKGROUND

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 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

October 1, 1999

Study Completion

October 1, 2007

Last Updated

June 20, 2013

Record last verified: 2004-08

Locations

US(1)