Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

NCT00020397 | Completed Phase 2

• 3 other identifiers: CDR0000068403NCI-01-C-0032NCI-2390
• 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: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Interventions

NY-ESO-1 peptide vaccine BIOLOGICAL

aldesleukin 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 that expresses ESO-1 antigen * Must have progressed during prior standard treatment * Measurable or evaluable disease * HLA-A\*201 or HLA-DPB1\*04 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: * SGOT and SGPT less than 3 times normal * Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No cardiac ischemia\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \*For interleukin-2 (IL-2) administration Pulmonary: * No obstructive or restrictive pulmonary disease (for IL-2 administration) Immunologic: * No autoimmune disease * No active primary or secondary immunodeficiency * HIV negative * No active systemic infections Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other active major medical illness (for IL-2 administration) PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior ESO-1 immunization Chemotherapy: * Recovered from any prior chemotherapy Endocrine therapy: * No concurrent systemic steroid therapy Radiotherapy: * Recovered from any prior radiotherapy Surgery: * Not specified Other: * At least 3 weeks since any prior systemic therapy for cancer * No other concurrent systemic therapy 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)

• Khong HT, Yang JC, Topalian SL, Sherry RM, Mavroukakis SA, White DE, Rosenberg SA. Immunization of HLA-A*0201 and/or HLA-DPbeta1*04 patients with metastatic melanoma using epitopes from the NY-ESO-1 antigen. J Immunother. 2004 Nov-Dec;27(6):472-7. doi: 10.1097/00002371-200411000-00007.

  PMID: 15534491 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin

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
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2000
• Study Completion: July 1, 2005
• Last Updated: June 19, 2013

Record last verified: 2005-01

Locations

US (1)