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Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma

This study has been completed.
Study NCT00019383.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma
Official Title  Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)
Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma.

Detailed Description

OBJECTIVES:

  • Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen, either alone or when combined with 1 of 3 adjuvants.
  • Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients.

OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31).

Patients are assigned to 1 of 4 vaccine groups:

  • Group 1 (HLA-A1 positive): Patients receive tyrosinase:240-251.
  • Group 2 (HLA-A3 positive): Patients receive gp100:17-25. (closed to accrual 5/17/2000)
  • Group 3 (HLA-A24 positive): Patients receive tyrosinase:206-214.
  • Group 4 (HLA-A31 positive): Patients receive tyrosinase related protein-1. Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF) SQ) depending on the time of entry into study and response to treatment.

At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study. If a second patient develops unacceptable toxicity, that schedule of peptide administration is discontinued.

Patients exhibiting stable, minor, mixed, or partial response may receive up to 12 additional courses.

Patients are followed for 4-6 weeks.

PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Melanoma (Skin)
Intervention  Drug: aldesleukin
Drug: incomplete Freund's adjuvant
Drug: sargramostim
Drug: tyrosinase peptide
Drug: tyrosinase-related protein-1
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  January 1998
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically proven refractory metastatic melanoma

    • Must be HLA-A1, HLA-A3, HLA-A24, or HLA-A31 positive
  • Measurable disease

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance Status:

  • ECOG 0-1

Life Expectancy:

  • Greater than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3
  • No coagulation disorder

Hepatic:

  • AST or ALT less than 2 times upper limit of normal
  • Bilirubin no greater than 1.6 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No major cardiovascular disease

Pulmonary:

  • No major respiratory disease

Other:

  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • Hepatitis B surface antigen negative
  • No known allergy to Montanide ISA-51
  • No active systemic infection
  • No immunodeficiency disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic therapy
  • No concurrent biologic therapy

Chemotherapy:

  • At least 3 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 3 weeks since prior endocrine therapy
  • No concurrent steroid therapy or other endocrine therapy

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Prior or concurrent surgery for melanoma allowed
Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00019383
Organization ID CDR0000065915
Secondary IDs †† NCI-98-C-0022, NCI-T97-0088
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Steven A. Rosenberg, MD, PhD     NCI - Surgery Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date June 2003
First Received Date  July 11, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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