Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
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|ClinicalTrials.gov Identifier: NCT00074230|
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : May 12, 2015
RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: Autologous Dendritic Cells loaded with MAGE-A3, MelanA and Survivin||Phase 1 Phase 2|
- Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin antigens in patients with stage IV cutaneous melanoma.
- Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine.
- Determine whether simultaneous loading of DC with keyhole limpet hemocyanin (KLH) significantly enhances induction of the Melan-A, MAGE-3, and survivin antigens in these patients.
- Determine clinical antitumor activity (e.g., objective tumor response, time to tumor progression, progression-free interval, and overall survival) in patients treated with this vaccine.
OUTLINE: This is an open-label, nonrandomized study.
- Phase I: Beginning 9-11 days before vaccination, patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). PBMCs are processed for the generation of dendritic cells (DC) to be used for vaccinations. PBMCs are transfected with RNAs encoding for Melan-A, MAGE-3, and survivin antigens. DC are pulsed with keyhole limpet hemocyanin (KLH) for some patients.
Patients receive antigen-pulsed (with or without KLH) DC vaccination subcutaneously (SC) on days 1, 15, 43, and 71 in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may proceed to the phase II portion of the study.
- Phase II: Patients undergo leukapheresis as in phase I on days 102, 354, and 690. Patients receive up to 6 additional booster vaccinations SC as in phase I on days 127, 185, 269, 356, 521, and 692.
Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3, MelanA, and Survivin Antigens|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
- Biological: Autologous Dendritic Cells loaded with MAGE-A3, MelanA and Survivin
Within cohort 1 patients received the vaccine intradermally; in cohort 2 the route of Administration was intravenous Infusion, half of the patients had additional loading with RNA coding for EL-Selektin; in cohort 3 the vaccines was again infused intravenously, the cells were matured not with MCM.mimic as in cohort 1 and 2 but either with TriMix or MCM-mimic plus CD40L-RNA.
- Safety and tolerability at every visit [ Time Frame: 3 months ]
- Overall survival as assessed by clinical staging (CT scan, positron emission tomography [PET]) every 3 months [ Time Frame: 3 months ]
- Time to progression as assessed by clinical staging (CT scan, PET) every 3 months [ Time Frame: 3 months ]
- Objective tumor response as assessed by clinical staging (CT scan, PET) every 3 months [ Time Frame: 3 months ]
- Duration of response as assessed by clinical staging (CT scan, PET) every 3 months [ Time Frame: 3 months ]
- Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit [ Time Frame: 3 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00074230
|Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen|
|Erlangen, Germany, D-91052|
|Principal Investigator:||Gerold Schuler||Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen|