Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00019721 | Completed Phase 2

• 3 other identifiers: CDR0000067051NCI-99-C-0092NCI-T99-0033
• 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. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 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 confirmed metastatic melanoma that has failed standard therapy * Measurable disease * HLA-A0201 positive 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 (less than 3.0 mg/dL for patients with Gilbert's syndrome) * AST/ALT less than 3 times normal * Hepatitis B surface antigen negative * No coagulation disorder Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No major cardiovascular disease * If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only Pulmonary: * No major respiratory disease Other: * Not pregnant * Fertile patients must use effective contraception * HIV negative * No active systemic infection * No autoimmune disease or immunodeficiency disease * No primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy * No prior MART-1 antigen immunization 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 allowed

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)

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

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
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: August 7, 2003
• Study Start: April 1, 1999
• Study Completion: June 1, 2003
• Last Updated: June 20, 2013

Record last verified: 2002-08

Locations

US (1)