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Randomized Comparison of Three Schedules of Peptide Immunization in Patients With Stage II or III, or Completely Resected Metastatic Melanoma


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

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Trial Information

Randomized Comparison of Three Schedules of Peptide Immunization in Patients With Stage II or III, or Completely Resected Metastatic Melanoma


OBJECTIVES:

- Compare the immunologic activity of three different schedules of peptide immunization
with gp100:209-217 (210M) or gp100:17-25 antigen and tyrosinase:368-376 (370D),
tyrosinase:240-251 (244S), tyrosinase:206-214 (closed to accrual 11/05/01), or
tyrosinase-related protein-1 (ORF3):1-9 peptide (closed to accrual 11/05/01) emulsified
in Montanide ISA-51 in patients with melanoma at high risk for recurrence.

- Compare the response rate to treatment with interleukin-2 (IL-2) after being immunized
with this regimen with the usual response rate to IL-2 in this patient population.

- Determine whether an exploratory cohort of HLA-A2-positive patients demonstrate
immunologic activity to immunization with 2 peptides emulsified together.

OUTLINE: This is a randomized study. Patients are stratified according to HLA type (A0201 vs
A1 vs A3 vs A24 vs A31). (HLA-A24 and HLA-A31 closed to accrual 11/05/01). Patients are
randomized to 1 of 3 treatment arms and are given an assigned vaccine, which is emulsified
in Montanide ISA-51.

- HLA typing:

- HLA-A2: gp100:209-217 (210M) and tyrosinase:368-376 (370D)

- HLA-A1: tyrosinase:240-251 (244S)

- HLA-A3: gp100:17-25

- HLA-A24: tyrosinase:206-214 (closed to accrual 11/05/01)

- HLA-A31: tyrosinase-related protein-1 (ORF3):1-9 (closed to accrual 11/05/01)

- Arm I: Patients receive assigned vaccine subcutaneously (SC) weekly for 10 weeks
followed by 3 weeks of no treatment.

- Arm II: Patients receive assigned vaccine SC on days 1, 22, 43, and 64.

- Arm III: Patients receive assigned vaccine SC on days 1-4, 22-25, 43-46, and 64-67.

Treatment in all arms repeats every 13 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.

After the completion of the randomized arms of HLA-A2 patients, additional HLA-A2 patients
receive immunization with gp100:209-217 (210M) and tyrosinase:368-376 (370D) emulsified in
Montanide ISA-51 SC once every 3 weeks for 4 courses.

Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours
for up to 4 days. Treatment repeats every 10-14 days for at least 4 courses in the absence
of disease progression or unacceptable toxicity. Patients with stable disease or mixed or
partial response to treatment may receive additional courses every 2 months.

Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 324 patients (19-33 per arm for the HLA-A0201 stratum, 13-16
per arm for the other 4 strata, and 33 per the additional HLA-A2 cohort) will be accrued for
this study within 2 years. (HLA-A24 and HLA-A31 closed to accrual 11/05/01).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of melanoma, including one of the following characteristics:

- Lesions at least 1.5 mm in thickness

- At least 1 positive lymph node

- Ulcerated lesion

- Local recurrence

- Metastatic lesions completely resected within the past 6 months

- Clinically disease free within the past 6 weeks

- HLA-A1, A3, A24, A31, or 0201 positive (HLA-A24 and HLA-A31 closed to accrual
11/05/01)

- No ocular or mucosal melanoma

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 90,000/mm^3

Hepatic:

- Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL in Gilbert's syndrome)

- AST and ALT less than 3 times normal

- Hepatitis B surface antigen negative

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- For interleukin-2 (IL-2) therapy:

- No cardiac ischemia, myocardial infarction, or cardiac arrhythmias

- Stress cardiac test required if abnormal EKG, symptoms of cardiac ischemia or
arrhythmia, or older than 50 years

Pulmonary:

- For IL-2 therapy:

- No obstructive or restrictive pulmonary disease

- FEV_1 greater than 60% predicted if prolonged history of cigarette smoking or
symptoms of respiratory dysfunction

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No active systemic infections, autoimmune disease, or active primary or secondary
immunodeficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior systemic biologic therapy for melanoma

- No prior gp100 antigen or tyrosinase or TRP-1 peptide

- No other concurrent systemic biologic therapy for melanoma

Chemotherapy:

- At least 3 weeks since prior systemic chemotherapy and recovered

- No concurrent systemic chemotherapy for melanoma

Endocrine therapy:

- At least 3 weeks since prior systemic endocrine therapy for melanoma

- No concurrent systemic steroid therapy

Radiotherapy:

- At least 3 weeks since prior systemic radiotherapy and recovered

- No concurrent systemic radiotherapy for melanoma

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, 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:

CDR0000068299

NCT ID:

NCT00020358

Start Date:

September 2000

Completion Date:

October 2007

Related Keywords:

  • Melanoma (Skin)
  • stage I melanoma
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182