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Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen


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

Thank you

Trial Information

Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen


OBJECTIVES:

Primary

- Compare the clinical response in patients with metastatic melanoma immunized with
recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without
gp100:209-217 (210M) peptide.

Secondary

- Compare the toxicity profile of these immunizations in these patients.

OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 cohorts according to
HLA-A2*0201 status. Patients assigned to cohort 1 are then randomized to 1 of 2 treatment
arms.

- Cohort 1 (HLA-A2*0201-positive patients): Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive immunization comprising recombinant gp100 protein (184V)
emulsified in Montanide ISA-51 subcutaneously (SC) on days 1, 22, 43, and 64 (1
course).

- Arm II: Patients receive immunization comprising recombinant gp100 protein (184V)
and gp100:209-217 (210M) peptide emulsified in Montanide ISA-51 SC on days 1, 22,
43, and 64 (1 course).

- Cohort 2 (HLA-A2*0201-negative patients): Patients receive immunization as in cohort 1,
arm I.

In both cohorts, treatment continues in the absence of rapid disease progression or
unacceptable toxicity.

In both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. Patients
achieving stable disease or a partial response receive retreatment according to their
assigned cohort. Patients with progressive disease who are eligible for interleukin-2 (IL-2)
receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes
3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). Patients receive up to 3
retreatment courses. Patients achieving a complete response (CR) receive 1 retreatment
course beyond CR. Patients with progressive disease who are ineligible for IL-2
administration are removed from the study.

PROJECTED ACCRUAL: A total of 45-75 patients (30-50 for cohort 1 [15-25 per treatment arm]
and 15-25 for cohort 2) will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of metastatic melanoma

- Measurable disease

- Progressive disease during or after prior standard treatment with or without
interleukin-2

PATIENT CHARACTERISTICS:

Age

- 16 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 6 months

Hematopoietic

- WBC at least 3,000/mm^3

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

- Lymphocyte count greater than 500/mm^3

Hepatic

- Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's
syndrome)

- ALT and AST less than 3 times normal

- Hepatitis B surface antigen negative

Renal

- Creatinine no greater than 2.0 mg/dL

Cardiovascular

- No symptomatic cardiac disease

Immunologic

- No active systemic infection

- No autoimmune disease

- No known immunodeficiency disease

- No known hypersensitivity to study agents

- No form of primary or secondary immunodeficiency

- No opportunistic infection

- HIV negative

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior gp100 peptide vaccine

Chemotherapy

- More than 6 weeks since prior nitrosoureas

Endocrine therapy

- No concurrent systemic steroid therapy

Radiotherapy

- Not specified

Surgery

- Prior recent (within the past 3 weeks) minor surgical procedures allowed

Other

- Recovered from prior therapy (toxicity no greater than grade 1)

- More than 3 weeks since prior systemic anticancer therapy

- No other concurrent systemic anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000335441

NCT ID:

NCT00072085

Start Date:

September 2003

Completion Date:

July 2006

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

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