Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine ,
allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa
2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma
patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).
The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de
Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).
Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and
36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.
CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then
one dose every two months for the first year and them every three months for the second year.
Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines,
not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day
and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.
IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for
four weeks and then 5 MU (3t/w) for 23 months.
Both treatments will also compare quality of life (QOL) and study a possible correlation in
the CSF470 vaccine arm between the induced immune response and clinical outcome