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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.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022438
  Purpose

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)
Drug: aldesleukin
Drug: incomplete Freund's adjuvant
Drug: recombinant tyrosinase-related protein-2
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

Drug Information available for:   Aldesleukin    Tyrosinase    Interleukin-2    Freund's adjuvant    Montanide ISA 51    Tryptophan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control
Official Title:   Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-Related Protein 2 (TRP-2)

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

Study Start Date:   June 2001

Detailed Description:

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.

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

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022438

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Steven A. Rosenberg, MD, PhD     NCI - Surgery Branch    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068818, NCI-01-C-0193, NCI-5369
First Received:   August 10, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00022438
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Tryptophan
Neuroectodermal Tumors
Aldesleukin
Interleukin-2
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Freund's Adjuvant
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 19, 2008




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