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.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022438
First received: August 10, 2001
Last updated: June 17, 2013
Last verified: July 2004

August 10, 2001
June 17, 2013
June 2001
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Complete list of historical versions of study NCT00022438 on ClinicalTrials.gov Archive Site
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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment
Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: aldesleukin
  • Biological: incomplete Freund's adjuvant
  • Biological: recombinant tyrosinase-related protein-2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2004
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DISEASE CHARACTERISTICS:

  • 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

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
  • No coagulation disorders

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

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

Pulmonary:

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

Immunologic:

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

Other:

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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent therapy for melanoma
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022438
CDR0000068818, NCI-01-C-0193, NCI-5369
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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)
July 2004

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