- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003229
Vaccine Therapy in Treating Patients With Metastatic Melanoma Who Are Undergoing Surgery for Lymph Node and Tumor Removal
A Phase I-II Trial of Antigen-Pulsed Autologous Dendritic Cells for Induction of Anti-Tumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma
RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill the tumor cells.
PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from white blood cells and melanoma cells in treating patients with metastatic melanoma who are undergoing surgery for lymph node and tumor removal.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the safety and toxicity of intravenous injections of autologous cultured dendritic cells pulsed with either gp100 and tyrosinase peptides or autologous melanoma tumor cell lysates in patients with metastatic melanoma. II. Determine whether treatment with melanoma tumor antigen pulsed autologous dendritic cells results in increased in vitro tumor specific cytotoxic T-cell responses. III. Determine whether this treatment can induce positive skin test responses to tumor antigens. IV. Evaluate the disease free and overall survival of these patients.
OUTLINE: This is a randomized, dose escalation study. Approximately 1-2 weeks following surgical lymphadenectomy, patients undergo leukapheresis to collect dendritic cells and are then divided into 3 groups. Group A consists of patients without adequate tumor for preparation of tumor lysate and who have tumors that express tyrosinase or gp100 with types HLA-A1, A2, or A3. Group B consists of the patients who have adequate tumor for lysate preparation but who do not type for HLA-A1, A2, or A3 (required for the peptide pulsed protocol). Group C are the patients with adequate tumor who are eligible for the peptide pulsed protocol. Group A patients receive autologous dendritic cells pulsed with appropriate peptide antigens. Group B patients are treated with autologous dendritic cells pulsed with autologous tumor cell lysates. Group C patients are randomized to receive dendritic cells pulsed with either peptide antigens or tumor lysate. All patients are administered intravenous active immunotherapy for 4 monthly intervals. The dose of the immunizations is escalated for each cohort of three patients that is accrued in each of the groups mentioned above. Each immunization at each dose level is followed by three days of interleukin-2 administered subcutaneously twice daily. Patients are followed at least 5 years for survival.
PROJECTED ACCRUAL: There will be 100 patients accrued in this study over 2 years. There will be 50, 20, and 30 patients in groups A, B, and C, respectively.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- Cancer Center, University of Virginia HSC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma involving cervical, axillary, inguinal, groin, or iliac lymph nodes All gross disease is resected at the time of surgical lymphadenectomy No distant metastases
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.4 mg/dL AST or ALT no greater than 1.5 times normal No active hepatitis Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No congestive heart failure, unstable angina, or current symptomatic arrhythmias Other: HIV negative No autoimmune diseases (e.g., lupus erythematosus, multiple sclerosis, or ankylosing spondylitis) No condition that would be considered as a contraindication for surgery Not pregnant or nursing Adequate contraception required for all fertile patients
PRIOR CONCURRENT THERAPY: At least 4 weeks since prior therapy for melanoma Biologic therapy: At least 3 months since prior interferon therapy Chemotherapy: No active immunosuppression due to prior chemotherapy Endocrine therapy: No active immunosuppression due to steroid therapy Radiotherapy: Not specified Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Hilliard F. Seigler, MD, Duke Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
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
- CDR0000066097
- DUMC-719975
- DUMC-0932-99-5R2
- DUMC-759-99-5R2
- UVA-HIC-7454
- NCI-G98-1398
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.
Clinical Trials on Melanoma (Skin)
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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William CarsonSchering-PloughCompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Roswell Park Cancer InstituteCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IIIA Skin MelanomaUnited States, Australia
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Emory UniversityGenentech, Inc.RecruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Incyte Corporation; University of VirginiaCompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IV Uveal Melanoma | Stage IIIA Skin Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal Melanoma | Recurrent Uveal MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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