Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen
16 Years
N/A
Both
Melanoma (Skin)
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 Support | Bethesda, Maryland 20892-1182 |
| NCI - Center for Cancer Research | Bethesda, Maryland 20892 |
