Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
16 Years
N/A
Both
Melanoma (Skin)
Trial Information
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
OBJECTIVES:
- Determine whether an immunologic response can be obtained after administration of ESO-1
peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04
positive patients with refractory metastatic melanoma expressing ESO-1.
- Determine the toxicity of this vaccine in these patients.
- Determine whether prior immunization with this vaccine results in increased clinical
responsiveness in patients treated with interleukin-2.
OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type.
- Group 1 (HLA-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine
comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides
subcutaneously once every 3 weeks for 4 courses in the absence of disease progression
or unacceptable toxicity.
- Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide
vaccine as in group I comprising class I peptide only.
- Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients receive ESO-1 peptide
vaccine as in group I comprising class II peptide only.
Patients who develop disease progression discontinue vaccinations and receive high-dose
interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses).
Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease
progression (after at least 2 courses) or unacceptable toxicity.
Patients who have stable disease or a mixed or partial response to vaccination or IL-2
therapy may be eligible for additional vaccine therapy. Patients who have a complete
response to vaccine therapy are eligible for 1 additional treatment.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 45-90 patients (15-30 per treatment group) will be accrued for
this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic melanoma that expresses ESO-1 antigen
- Must have progressed during prior standard treatment
- Measurable or evaluable disease
- HLA-A*201 or HLA-DPB1*04 positive
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:
- SGOT and SGPT less than 3 times normal
- Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
- Hepatitis B surface antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No cardiac ischemia*
- No myocardial infarction*
- No cardiac arrhythmias* NOTE: *For interleukin-2 (IL-2) administration
Pulmonary:
- No obstructive or restrictive pulmonary disease (for IL-2 administration)
Immunologic:
- No autoimmune disease
- No active primary or secondary immunodeficiency
- HIV negative
- No active systemic infections
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active major medical illness (for IL-2 administration)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior ESO-1 immunization
Chemotherapy:
- Recovered from any prior chemotherapy
Endocrine therapy:
- No concurrent systemic steroid therapy
Radiotherapy:
- Recovered from any prior radiotherapy
Surgery:
- Not specified
Other:
- At least 3 weeks since any prior systemic therapy for cancer
- No other concurrent systemic therapy 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:
CDR0000068403
NCT ID:
NCT00020397
Start Date:
November 2000
Completion Date:
July 2005
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
