- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072085
Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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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Bethesda, Maryland, United States, 20892
- NCI - Center for Cancer Research
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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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
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
- 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
- CDR0000335441
- NCI-03-C-0299
- NCI-6210
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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