A Phase 2 interventional study of DC vaccination and DC vaccination with cisplatinum in Melanoma, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by Radboud University Medical Center · Phase 2, Interventional, and Treatment
This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. This study will provide important data on the immunological efficacy of DC immunochemotherapy.
Rationale Investigators have explored immunotherapy and have now vaccinated well over 200 stage III and IV melanoma patients in the Netherlands with monocyte-derived dendritic cell (DC) vaccines and proved that DC therapy is safe with minimal side effects.
Cytotoxic chemotherapy and radiotherapy have long been viewed as strategies that directly impact the viability of the tumor cell, and that the immune system contributed little to their efficacy. The commonly held opinion was that chemotherapy and immunotherapy could not be combined because of the myelo-suppressive effect of most chemotherapeutic agents. However, it becomes increasingly obvious that chemotherapy also possess the capacity to trigger tumor antigen release and danger signals in a manner that provokes engagement of innate and adaptive immunity that may be capitalized upon.
Small proof-of-concept clinical trials in cancer patients indicate that the efficacy of anti-cancer vaccines may indeed be enhanced by chemotherapy [2]. Also preliminary observations indicate that chemotherapeutic agents, in particular platinum compounds (cisplatin, carboplatin and oxaliplatin) are immunogenic and may contribute to reverse tumor cell induced immunosuppression/immune deviation.
Investigators hypothesize that DC vaccination, when combined with other more conventional anti-tumor treatments such as chemotherapy, that eradicate large numbers of cancer cells, may allow the T cells to clear the remaining cancer cells and to provide immunological memory to prevent relapse.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 54 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients:
and in addition: Stage III melanoma
Exclusion Criteria:
mature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase
Biological: DC vaccination
mature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase. each DC vaccine will be preceded by cisplatin infusion: 50 mg/m2, 1-2h before DC injection.
Biological: DC vaccination with cisplatinum
DC vaccination without cisplatinum
DC vaccination with cisplatinum
Immunogenicity: number of participants with KLH and/or tumor-specific antigens immune responses.
Time frame: 5 years
Feasibility: % of vaccines meeting the release criteria.
Time frame: 5 years
Toxicity: number of Participants with Adverse Events.
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Best objective response (only in stage IV)
Time frame: 5 years
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center