Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT00019994 | Completed Phase 2

• 3 other identifiers: CDR0000067391NCI-99-C-0159NCI-T99-0079
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to 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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

MART-1 antigen BIOLOGICAL

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: * Histologically proven metastatic melanoma that has failed standard treatment * HLA-DRB1\*0401 positive * Known HLA-A0201 status PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * AST or ALT 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 autoimmune disease * No primary or secondary immunodeficiency disease * HIV negative Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active systemic infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunization to the entire gp100 molecule * At least 3 weeks since prior gp100:209-217 antigen peptide * At least 3 weeks since other prior biologic therapy Chemotherapy: * At least 3 weeks since prior chemotherapy Endocrine therapy: * At least 3 weeks since prior endocrine therapy * No concurrent steroid therapy Radiotherapy: * At least 3 weeks since prior radiotherapy Surgery: * Prior surgery for cancer allowed Other: * At least 3 weeks since any prior therapy except surgery for cancer

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 (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

• Phan GQ, Touloukian CE, Yang JC, Restifo NP, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, Seipp CA, Freezer LJ, Morton KE, Mavroukakis SA, White DE, Rosenberg SA. Immunization of patients with metastatic melanoma using both class I- and class II-restricted peptides from melanoma-associated antigens. J Immunother. 2003 Jul-Aug;26(4):349-56. doi: 10.1097/00002371-200307000-00007.

  PMID: 12843797 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

MART-1 Antigen; 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

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors

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 19, 2013

Record last verified: 2003-03

Locations

US (1)