Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

NCT00072085 | Completed Phase 2

• 3 other identifiers: CDR0000335441NCI-03-C-0299NCI-6210
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Measurable disease * Progressive disease during or after prior standard treatment with or without interleukin-2 PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 * Lymphocyte count greater than 500/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * ALT and AST less than 3 times normal * Hepatitis B surface antigen negative Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No symptomatic cardiac disease Immunologic * No active systemic infection * No autoimmune disease * No known immunodeficiency disease * No known hypersensitivity to study agents * No form of primary or secondary immunodeficiency * No opportunistic infection * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior gp100 peptide vaccine Chemotherapy * More than 6 weeks since prior nitrosoureas Endocrine therapy * No concurrent systemic steroid therapy Radiotherapy * Not specified Surgery * Prior recent (within the past 3 weeks) minor surgical procedures allowed Other * Recovered from prior therapy (toxicity no greater than grade 1) * More than 3 weeks since prior systemic anticancer therapy * No other concurrent systemic anticancer therapy

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 1, 2006
• Last Updated: June 19, 2013

Record last verified: 2005-05

Locations

US (2)