Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

NCT ID: NCT00072085

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-07-31

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.

Detailed Description

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

gp100 antigen

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Steven A. Rosenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

NCI - Center for Cancer Research

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-03-C-0299

Identifier Type: -

Identifier Source: secondary_id

NCI-6210

Identifier Type: -

Identifier Source: secondary_id

CDR0000335441

Identifier Type: -

Identifier Source: org_study_id

NCT00069043

Identifier Type: -

Identifier Source: nct_alias