Vaccine Therapy in Treating Patients With Melanoma

NCT00020358 | Completed Phase 2

• 3 other identifiers: CDR0000068299NCI-00-C-0216NCI-2391
• 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. Vaccine therapy may be an effective treatment for melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of three vaccine therapy regimens in treating patients who have melanoma.

Conditions

Melanoma (Skin)

Keywords

stage I melanoma; stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

tyrosinase peptide 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 melanoma, including one of the following characteristics: * Lesions at least 1.5 mm in thickness * At least 1 positive lymph node * Ulcerated lesion * Local recurrence * Metastatic lesions completely resected within the past 6 months * Clinically disease free within the past 6 weeks * HLA-A1, A3, A24, A31, or 0201 positive (HLA-A24 and HLA-A31 closed to accrual 11/05/01) * No ocular or mucosal melanoma PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 Hepatic: * Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL in Gilbert's syndrome) * AST and ALT less than 3 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * For interleukin-2 (IL-2) therapy: * No cardiac ischemia, myocardial infarction, or cardiac arrhythmias * Stress cardiac test required if abnormal EKG, symptoms of cardiac ischemia or arrhythmia, or older than 50 years Pulmonary: * For IL-2 therapy: * No obstructive or restrictive pulmonary disease * FEV\_1 greater than 60% predicted if prolonged history of cigarette smoking or symptoms of respiratory dysfunction Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active systemic infections, autoimmune disease, or active primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior systemic biologic therapy for melanoma * No prior gp100 antigen or tyrosinase or TRP-1 peptide * No other concurrent systemic biologic therapy for melanoma Chemotherapy: * At least 3 weeks since prior systemic chemotherapy and recovered * No concurrent systemic chemotherapy for melanoma Endocrine therapy: * At least 3 weeks since prior systemic endocrine therapy for melanoma * No concurrent systemic steroid therapy Radiotherapy: * At least 3 weeks since prior systemic radiotherapy and recovered * No concurrent systemic radiotherapy for melanoma Surgery: * See Disease Characteristics

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)

• Rosenberg SA, Sherry RM, Morton KE, Scharfman WJ, Yang JC, Topalian SL, Royal RE, Kammula U, Restifo NP, Hughes MS, Schwartzentruber D, Berman DM, Schwarz SL, Ngo LT, Mavroukakis SA, White DE, Steinberg SM. Tumor progression can occur despite the induction of very high levels of self/tumor antigen-specific CD8+ T cells in patients with melanoma. J Immunol. 2005 Nov 1;175(9):6169-76. doi: 10.4049/jimmunol.175.9.6169.

  PMID: 16237114 RESULT

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Study Completion: October 1, 2007
• Last Updated: June 19, 2013

Record last verified: 2003-03

Locations

US (1)