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Title: Allogeneic cells vaccine increases disease-free survival in stage III melanoma patients. A non randomized phase II study
Authors: Mordoh, Jose 
Kairiyama, Claudia 
Bover, Laura 
Solarolo, Elsa 
Keywords: Melanoma;Vacunas contra el Cáncer;Argentina
Issue Date: 1997
Description: The incidence of melanoma is increasing rapidly, and in many cases the primary tumor is excised after metastatic spreading. In 80% of the cases, the first metastatic site is in regional lymph nodes (AJCC Stage III). After excision of these nodes, the patient is clinically disease-free, but the chances of recurrency vary between 40-80%. Thirty patients with stage III melanoma were treated in a non-randomized Phase II adjuvant trial with a vaccine consisting of a mixture of three allogeneic cell lines: IIB-MEL-J, IIB-MEL-LES and IIB-MEL-IAN (5 x 10(6) cells each). The cells were irradiated (5,000 cGy) and BCG was used as nonspecific stimulant. Before each vaccination (72 hr) the patients received cyclophosphamide (300 mg/sqm). The untreated control group was composed of 24 Stage III melanoma patients. Vaccination started within 60 days after surgery, and patients received 4 vaccinations, one every 21 days and then 1 every two months during the 1st year; 1 every three months during the 2nd year, and 1 every 6 months during the 3rd, 4th and 5th years. The treated group was composed by 19 men (63.3%) and 11 women (36.7%); average age: 47.6 +/- 14.1 years (range: 16-70 yr). The control group was composed by 18 men (75%) and 6 women (25%); average age 49.8 +/- 14.2 yr (range: 26-73 yr). The median disease free survival (DFS) calculated according to Kaplan-Meier was 7.0 months in the control group vs 20.0 months in the treated group (p < 0.001). The results of this clinical trial suggest that treatment with allogeneic cell vaccines increases DFS in stage III melanoma patients.
Fil: Solarolo, Elsa. ANLIS Dr.C.G.Malbrán. Instituto Nacional de Microbiología; Argentina.
Fil: Mordoh, Jose. Instituto de Investigaciones Bioquímicas. Fundación Campomar; Argentina
Fil: Kairiyama, Claudia. Instituto de Investigaciones Bioquímicas. Fundación Campomar; Argentina
Fil: Bover, Laura. Instituto de Investigaciones Bioquímicas. Fundación Campomar; Argentina
ISSN: 0025-7680
Rights: info:eu-repo/semantics/openAccess
Appears in Collections:Publicaciones INPB

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