Phase II clinical trial of autologous dendritic cell vaccine with immunologic adjuvant in cutaneous melanoma patients

This paper describes the clinical results and immunologic changes in cutaneous melanoma patients receiving active specific immunotherapy with autologous dendritic cell vaccine (DCV) in combination with cyclophosphamide used as immunologic adjuvant. Twenty eight patients with morphologically verified...

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Bibliographic Details
Published in:	Voprosy onkologij Vol. 58; no. 2; p. 212
Main Authors:	Baldueva, I A, Novik, A V, Moiseenko, V M, Nekhaeva, T L, Danilova, A B, Danilov, A O, Protsenko, S A, Petrova, T Iu, Uleĭskaia, G I, Shchekina, L A, Semenova, A I, Mikhaĭlichenko, T D, Teletaeva, G M, Zhabina, A S, Volkov, N V, Komarov, Iu I
Format:	Journal Article
Language:	Russian
Published:	Russia (Federation) 2012
Subjects:	Adjuvants, Immunologic - administration & dosage Adjuvants, Immunologic - therapeutic use Adult Aged Antineoplastic Agents, Alkylating - therapeutic use Cancer Vaccines - immunology Cancer Vaccines - therapeutic use Cyclophosphamide - administration & dosage Cyclophosphamide - therapeutic use Dendritic Cells Disease Progression Drug Administration Schedule Female Humans Immunohistochemistry Immunotherapy - adverse effects Immunotherapy - methods Infusions, Intravenous Male Melanoma - immunology Melanoma - secondary Melanoma - therapy Middle Aged Neoplasm Staging Skin Neoplasms - immunology Skin Neoplasms - pathology Skin Neoplasms - therapy Time Factors Treatment Outcome
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Summary:	This paper describes the clinical results and immunologic changes in cutaneous melanoma patients receiving active specific immunotherapy with autologous dendritic cell vaccine (DCV) in combination with cyclophosphamide used as immunologic adjuvant. Twenty eight patients with morphologically verified stage III-IV cutaneous melanoma receiving therapy in N. N. Petrov Research Institute of Oncology between 2008 and 2011 were included in the study. All patients signed an informed consent form. Nineteen patients (67,9%) received DCV in therapeutic setting, 9 (32,1%) received it in adjuvant setting. DCV therapy was well tolerated. No serious adverse events were registered. Frequent adverse events included Grade 1-2 unspecific symptoms (fever, fatigue, flu-like symptoms) observed in 22% patients after 3,5% of vaccinations. In therapeutic settings the use DCV lead to clinical effect (PR+SD) in 36,6% of patients. PR was observed in 5% of (95% CI 0-15%) patients, SD in 31,6% (95% CI 13-56%). Duration of the objective responses was 168-965+days. Addition of immunologic adjuvant (cyclophosphamide 300 mg/m2 IV 2 hours) 3 days before vaccination increased its efficacy. In this patients group (n=12) the therapy lead to clinical benefit in 42% (95% CI 17-69%) of cases, median time to progression was 91 (95% CI 55-126) days. This regimen was selected for adjuvant therapy. In the adjuvant therapy group (n=9) the median time to progression was 112 (95% CI 58-166) days. Immunologic monitoring showed correlation ofT- and B-cell immune response with DCV clinical efficacy (p<0,05), no correlation with delayed hypersensivity reaction was observed (p>0,1). DCV is well tolerated and shows immunological and clinical response in stage III-IV skin melanoma patients.
ISSN:	0507-3758