- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020397
Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068403
- NCI-01-C-0032
- NCI-2390
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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