- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006113
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.
Study Overview
Status
Conditions
Intervention / Treatment
- Biological: aldesleukin
- Biological: recombinant interferon gamma
- Biological: gp100 antigen
- Biological: tyrosinase peptide
- Biological: sargramostim
- Biological: recombinant CD40-ligand
- Biological: therapeutic autologous dendritic cells
- Biological: MART-1 antigen
- Biological: therapeutic tumor infiltrating lymphocytes
- Biological: recombinant interleukin-4
- Radiation: Candida albicans skin test reagent
Detailed Description
OBJECTIVES:
- Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90089
- USC/Norris Comprehensive Cancer Center and Hospital
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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
- Measurable disease after attempted curative surgery
- Unresectable stage III or IV uveal melanoma
- Metastatic mucosal melanoma
- HLA-A2.1 positive
- No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 75,000/mm^3
- Hemoglobin at least 9.0 g/dL
- No coagulation disorders
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- Patients with documented or suspected coronary artery disease must undergo stress thallium test
- No major cardiovascular illness
Pulmonary:
- No major pulmonary illness
Immunologic:
- HIV negative
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- No history of uveitis or autoimmune inflammatory eye disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No major systemic infection
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens
Chemotherapy:
- At least 1 month since prior chemotherapy for melanoma
Endocrine therapy:
- No concurrent steroid therapy
Radiotherapy:
- At least 1 month since prior radiotherapy for melanoma
Surgery:
- See Disease Characteristics
Other:
- At least 1 month since prior adjuvant therapy for melanoma
- At least 1 month since other prior therapy for melanoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jeffrey S. Weber, MD, PhD, University of Southern California
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
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
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Aldesleukin
- Interferon-gamma
- Sargramostim
- Interleukin-4
Other Study ID Numbers
- CDR0000068125 (10M-99-1)
- LAC-USC-10M991
- NCI-G00-1837
- NCI-T99-0102
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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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 InstituteNational 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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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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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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Emory UniversityGenentech, Inc.Active, not 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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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
-
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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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
Clinical Trials on aldesleukin
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National Cancer Institute (NCI)CompletedMetastatic Melanoma | Renal Cell CancerUnited States
-
Cancer Biotherapy Research GroupUnknownKidney CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Blumenthal Cancer Center at Carolinas Medical CenterUnknown
-
Northwestern UniversityNational Cancer Institute (NCI)Terminated
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Chiron CorporationCompleted
-
Blumenthal Cancer Center at Carolinas Medical CenterUnknown
-
Cancer Biotherapy Research GroupUnknownLung CancerUnited States
-
St. Anna KinderkrebsforschungUnknown
-
National Cancer Institute (NCI)Completed