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Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)


Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000065915

NCT ID:

NCT00019383

Start Date:

January 1998

Completion Date:

June 2003

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • Melanoma

Name

Location

Surgery BranchBethesda, Maryland  20892