Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens
16 Years
N/A
Both
Melanoma (Skin)
Trial Information
Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens
OBJECTIVES:
- Determine the clinical response to immunization using gp100:44-59 antigen peptide plus
gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with
metastatic melanoma who are HLA-DRB1*0401 and HLA-A0201 positive.
- Determine the clinical response to immunization using gp100:44-59 antigen peptide alone
in patients with metastatic melanoma who are HLA-DRB1*0401 positive but HLA-A0201
negative.
- Determine the immunologic response in patients treated with these regimens as measured
by changes in T-cell precursors from before to after treatment.
- Evaluate the toxicity profiles of these regimens in these patients.
OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status
and prior gp100:209-217 (210M) antigen peptide immunization:
- Group 1 (HLA-A0201 positive and no prior gp100:209-217 [210M] antigen peptide):
Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified
together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and
MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC.
- Group 2 (HLA-A0201 positive and prior gp100:209-217 [210M] antigen peptide): Patients
receive treatment as in group 1.
- Group 3 (HLA-A0201 negative and no prior gp100:209-217 [210M] antigen peptide):
Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone.
- All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease
progression or unacceptable toxicity. Patients with complete response after 4 doses
receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed,
or partial response after 4 doses receive a maximum of 12 additional doses. Patients
with no response after 4 doses receive immunization with the same peptides and
interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1
day after each immunization.
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued
for this study within 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven metastatic melanoma that has failed standard treatment
- HLA-DRB1*0401 positive
- Known HLA-A0201 status
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- AST or ALT 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 autoimmune disease
- No primary or secondary immunodeficiency disease
- HIV negative
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active systemic infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunization to the entire gp100 molecule
- At least 3 weeks since prior gp100:209-217 antigen peptide
- At least 3 weeks since other prior biologic therapy
Chemotherapy:
- At least 3 weeks since prior chemotherapy
Endocrine therapy:
- At least 3 weeks since prior endocrine therapy
- No concurrent steroid therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy
Surgery:
- Prior surgery for cancer allowed
Other:
- At least 3 weeks since any prior therapy except surgery for cancer
Type of Study:
Interventional
Study Design:
Masking: Open Label, 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:
CDR0000067391
NCT ID:
NCT00019994
Start Date:
October 1999
Completion Date:
October 2007
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 |
