Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 11, 2001
Last updated: June 18, 2013
Last verified: January 2005

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.

Condition Intervention Phase
Melanoma (Skin)
Biological: NY-ESO-1 peptide vaccine
Biological: aldesleukin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Study Completion Date: July 2005
Detailed Description:


  • Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04 positive patients with refractory metastatic melanoma expressing ESO-1.
  • Determine the toxicity of this vaccine in these patients.
  • Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2.

OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type.

  • Group 1 (HLA-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only.
  • Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only.

Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity.

Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy. Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3


  • 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


  • Creatinine no greater than 2.0 mg/dL


  • No cardiac ischemia*
  • No myocardial infarction*
  • No cardiac arrhythmias* NOTE: *For interleukin-2 (IL-2) administration


  • No obstructive or restrictive pulmonary disease (for IL-2 administration)


  • No autoimmune disease
  • No active primary or secondary immunodeficiency
  • HIV negative
  • No active systemic infections


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active major medical illness (for IL-2 administration)


Biologic therapy:

  • No prior ESO-1 immunization


  • Recovered from any prior chemotherapy

Endocrine therapy:

  • No concurrent systemic steroid therapy


  • Recovered from any prior radiotherapy


  • Not specified


  • At least 3 weeks since any prior systemic therapy for cancer
  • No other concurrent systemic therapy for cancer
  Contacts and Locations
Please refer to this study by its identifier: NCT00020397

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Additional Information:
Publications: Identifier: NCT00020397     History of Changes
Obsolete Identifiers: NCT00006491
Other Study ID Numbers: CDR0000068403, NCI-01-C-0032, NCI-2390
Study First Received: July 11, 2001
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on April 23, 2014