Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020397
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

July 11, 2001
January 27, 2003
June 19, 2013
November 2000
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Complete list of historical versions of study NCT00020397 on Archive Site
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Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen

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.


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: NY-ESO-1 peptide vaccine
  • Biological: aldesleukin
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2005
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  • 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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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National Cancer Institute (NCI)
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Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
National Cancer Institute (NCI)
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP