- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020358
Vaccine Therapy in Treating Patients With Melanoma
Randomized Comparison of Three Schedules of Peptide Immunization in Patients With Stage II or III, or Completely Resected Metastatic Melanoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be an effective treatment for melanoma.
PURPOSE: Randomized phase II trial to study the effectiveness of three vaccine therapy regimens in treating patients who have melanoma.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Compare the immunologic activity of three different schedules of peptide immunization with gp100:209-217 (210M) or gp100:17-25 antigen and tyrosinase:368-376 (370D), tyrosinase:240-251 (244S), tyrosinase:206-214 (closed to accrual 11/05/01), or tyrosinase-related protein-1 (ORF3):1-9 peptide (closed to accrual 11/05/01) emulsified in Montanide ISA-51 in patients with melanoma at high risk for recurrence.
- Compare the response rate to treatment with interleukin-2 (IL-2) after being immunized with this regimen with the usual response rate to IL-2 in this patient population.
- Determine whether an exploratory cohort of HLA-A2-positive patients demonstrate immunologic activity to immunization with 2 peptides emulsified together.
OUTLINE: This is a randomized study. Patients are stratified according to HLA type (A0201 vs A1 vs A3 vs A24 vs A31). (HLA-A24 and HLA-A31 closed to accrual 11/05/01). Patients are randomized to 1 of 3 treatment arms and are given an assigned vaccine, which is emulsified in Montanide ISA-51.
HLA typing:
- HLA-A2: gp100:209-217 (210M) and tyrosinase:368-376 (370D)
- HLA-A1: tyrosinase:240-251 (244S)
- HLA-A3: gp100:17-25
- HLA-A24: tyrosinase:206-214 (closed to accrual 11/05/01)
- HLA-A31: tyrosinase-related protein-1 (ORF3):1-9 (closed to accrual 11/05/01)
- Arm I: Patients receive assigned vaccine subcutaneously (SC) weekly for 10 weeks followed by 3 weeks of no treatment.
- Arm II: Patients receive assigned vaccine SC on days 1, 22, 43, and 64.
- Arm III: Patients receive assigned vaccine SC on days 1-4, 22-25, 43-46, and 64-67.
Treatment in all arms repeats every 13 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
After the completion of the randomized arms of HLA-A2 patients, additional HLA-A2 patients receive immunization with gp100:209-217 (210M) and tyrosinase:368-376 (370D) emulsified in Montanide ISA-51 SC once every 3 weeks for 4 courses.
Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours for up to 4 days. Treatment repeats every 10-14 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or mixed or partial response to treatment may receive additional courses every 2 months.
Patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 324 patients (19-33 per arm for the HLA-A0201 stratum, 13-16 per arm for the other 4 strata, and 33 per the additional HLA-A2 cohort) will be accrued for this study within 2 years. (HLA-A24 and HLA-A31 closed to accrual 11/05/01).
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 melanoma, including one of the following characteristics:
- Lesions at least 1.5 mm in thickness
- At least 1 positive lymph node
- Ulcerated lesion
- Local recurrence
- Metastatic lesions completely resected within the past 6 months
- Clinically disease free within the past 6 weeks
- HLA-A1, A3, A24, A31, or 0201 positive (HLA-A24 and HLA-A31 closed to accrual 11/05/01)
- No ocular or mucosal melanoma
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
Hepatic:
- Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL in Gilbert's syndrome)
- AST and ALT less than 3 times normal
- Hepatitis B surface antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
For interleukin-2 (IL-2) therapy:
- No cardiac ischemia, myocardial infarction, or cardiac arrhythmias
- Stress cardiac test required if abnormal EKG, symptoms of cardiac ischemia or arrhythmia, or older than 50 years
Pulmonary:
For IL-2 therapy:
- No obstructive or restrictive pulmonary disease
- FEV_1 greater than 60% predicted if prolonged history of cigarette smoking or symptoms of respiratory dysfunction
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active systemic infections, autoimmune disease, or active primary or secondary immunodeficiency
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior systemic biologic therapy for melanoma
- No prior gp100 antigen or tyrosinase or TRP-1 peptide
- No other concurrent systemic biologic therapy for melanoma
Chemotherapy:
- At least 3 weeks since prior systemic chemotherapy and recovered
- No concurrent systemic chemotherapy for melanoma
Endocrine therapy:
- At least 3 weeks since prior systemic endocrine therapy for melanoma
- No concurrent systemic steroid therapy
Radiotherapy:
- At least 3 weeks since prior systemic radiotherapy and recovered
- No concurrent systemic radiotherapy for melanoma
Surgery:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Aldesleukin
- Freund's Adjuvant
Other Study ID Numbers
- CDR0000068299
- NCI-00-C-0216
- NCI-2391
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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