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Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00020397
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Masking: None (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
Study Start Date : November 2000
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Aldesleukin
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020397

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

ClinicalTrials.gov Identifier: NCT00020397     History of Changes
Obsolete Identifiers: NCT00006491
Other Study ID Numbers: CDR0000068403
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: January 2005

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
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents