Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 10, 2001
Last updated: June 17, 2013
Last verified: July 2004

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: incomplete Freund's adjuvant
Biological: recombinant tyrosinase-related protein-2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)

Resource links provided by NLM:

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

Study Start Date: June 2001
Study Completion Date: August 2004
Detailed Description:


  • Determine the clinical responses in patients with HLA-A0201-positive refractory metastatic melanoma treated with tyrosinase-related protein-2:180-188 peptide vaccine alone.
  • Determine the clinical response rate of patients who have an immediate need to receive interleukin-2 (IL-2) in addition to this vaccine.
  • Compare the immunologic response, in terms of changes in T-cell precursors before and after treatment, in patients treated with this vaccine with or without IL-2.
  • Compare the toxicity profile of these regimens in these patients.

OUTLINE: This is a randomized, open-label study.

Patients who need immediate interleukin-2 (IL-2) receive tyrosinase-related protein-2 (TRP-2):180-188 peptide vaccine emulsified with Montanide ISA-51 on day 1 and high-dose IL-2 IV over 15 minutes once every 8 hours on days 2-5. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who do not need immediate IL-2 are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51 subcutaneously (SC) on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51 SC once weekly on weeks 1-4. Treatment repeats every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who have a complete response (CR) receive 1 additional course after achieving CR. Patients who have progressive disease while receiving vaccine alone may cross over to receive peptide vaccine with IL-2 for at least 2 courses.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A maximum of 83 patients (19-33 who need immediate interleukin-2 (IL-2); 15-25 per treatment arm who do not need immediate IL-2) 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

    • Refractory to standard therapy
    • No resectable locoregional disease
  • HLA-A0201 positive
  • Measurable disease
  • Previously resected brain metastases, brain metastases stable after prior radiosurgery, or brain metastases less than 1 cm and without edema allowed



  • 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
  • No coagulation disorders


  • Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen negative


  • Creatinine no greater than 2.0 mg/dL


  • No major medical illness of the cardiovascular system
  • No cardiac ischemia*
  • No myocardial infarction*
  • No cardiac arrhythmias* NOTE: * For interleukin-2 (IL-2) administration


  • No major medical illness of the respiratory system
  • No obstructive or restrictive pulmonary disease (for IL-2 administration)


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


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 3 weeks since prior biologic therapy for melanoma
  • No prior immunization to tyrosinase-related protein-2 antigen
  • No other concurrent biologic therapy for melanoma


  • At least 3 weeks since prior chemotherapy for melanoma and recovered
  • No concurrent chemotherapy for melanoma

Endocrine therapy:

  • At least 3 weeks since prior endocrine therapy for melanoma
  • No concurrent systemic steroid therapy
  • No concurrent endocrine therapy for melanoma


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy for melanoma and recovered
  • No concurrent radiotherapy for melanoma


  • See Disease Characteristics


  • No other concurrent therapy for melanoma
  Contacts and Locations
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Please refer to this study by its identifier: NCT00022438

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
  More Information

Additional Information:
No publications provided Identifier: NCT00022438     History of Changes
Obsolete Identifiers: NCT00017849
Other Study ID Numbers: CDR0000068818, NCI-01-C-0193, NCI-5369
Study First Received: August 10, 2001
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 09, 2015