A phase I/IIa clinical trial in stage IV melanoma of an autologous tumor-dendritic cell fusion (dendritoma) vaccine with low dose interleukin-2.

Autor: Greene JM; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA., Schneble EJ; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA., Jackson DO; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA., Hale DF; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA. diane.f.hale.mil@mail.mil., Vreeland TJ; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA., Flores M; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA., Martin J; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA., Herbert GS; General Surgery Department, San Antonio Military Medical Center, 3851 Roger Brooke Drive, Joint Base San Antonio-Ft. Sam Houston, TX, USA., Hardin MO; General Surgery Department, Madigan Army Medical Center, 9040 Jackson Ave., Tacoma, 98431, WA, USA., Yu X; Clemson University, Clemson, SC, USA., Wagner TE; Perseus PCI, Greenville, SC, USA., Peoples GE; Cancer Vaccine Development Program, 600 Navarro Street, Suite 500, San Antonio, TX, 78205, USA. georgepeoples2@hotmail.com.; Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD, USA. georgepeoples2@hotmail.com.
Jazyk: angličtina
Zdroj: Cancer immunology, immunotherapy : CII [Cancer Immunol Immunother] 2016 Apr; Vol. 65 (4), pp. 383-92. Date of Electronic Publication: 2016 Feb 19.
DOI: 10.1007/s00262-016-1809-6
Abstrakt: Background: Stage IV melanoma has high mortality, largely unaffected by traditional therapies. Immunotherapy including cytokine therapies and checkpoint inhibitors improves outcomes, but has significant toxicities. In this phase I/IIa trial, we investigated safety and efficacy of a dendritoma vaccine, an active, specific immunotherapy, in stage IV melanoma patients.
Methods: Autologous tumor lysate and dendritic cells were fused creating dendritoma vaccines for each patient. Phase I patients were vaccinated every 3 months with IL-2 given for 5 days after initial inoculation. Phase IIa patients were vaccinated every 6 weeks with IL-2 given on days 1, 3 and 5 after initial inoculation. Toxicity and clinical outcomes were assessed.
Results: Twenty-five patients were enrolled and inoculated. All dendritoma and IL-2 toxicities were Conclusions: The dendritoma vaccine has minimal toxicity profile with potential clinical benefit. There was OS advantage for NED stage IV patients, those receiving higher number of doses and increased frequency. Based on these results, we initiated a phase IIb trial utilizing improved dendritoma technology in the adjuvant setting for NED stage III/IV melanoma patients.
Databáze: MEDLINE
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