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Vaccine Therapy in Treating Patients With Metastatic Melanoma Who Are Undergoing Surgery for Lymph Node and Tumor Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003229
Recruitment Status : Completed
First Posted : August 25, 2004
Last Update Posted : March 25, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: aldesleukin Biological: gp100 antigen Biological: tyrosinase peptide Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase I-II Trial of Antigen-Pulsed Autologous Dendritic Cells for Induction of Anti-Tumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma
Study Start Date : July 1997
Actual Primary Completion Date : April 2000
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003229

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Hilliard F. Seigler, MD Duke Cancer Institute
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Responsible Party: Duke University Identifier: NCT00003229    
Other Study ID Numbers: CDR0000066097
First Posted: August 25, 2004    Key Record Dates
Last Update Posted: March 25, 2013
Last Verified: March 2013
Keywords provided by Duke University:
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents