• 18 years old or older with histologic diagnosis of ES SCLC
• All patients were treated conventional cytotoxic chemotherapy prior to receiving the vaccine
• 8 patients with cisplatin, 18 patients with carboplatin, 3 patients with cisplatin/CPT-11
• 29 patients enrolled in the study ages 39-76 years old with median age of 63
• Mononuclear cells for DC production were obtained after leukapheresis
• After thawing, cells were placed in X-VIVO-15 medium in tissue culture flasks at a concentration of 1.3 to 1.7×106 cells/cm2 of available culturing surface
• After 2 hours of culture, nonadherent cells were removed and the flask were recharged with X-VIVO-15 medium supplemented with 5ng/mL GMC-SF and 5ng/mL IL-4
• The flask was incubated for 48 hours at which time additional cytokine-supplemented medium was added to the flask, incubated for additional 72 hours
• After the completion of incubation, the nonadherent and loosely adherent cells were collected and used for 2hour infection with Adp53 at a viral particle to all ration of 15,000:1.
The vaccine was administered Intradermally (ID) injection at 2 week interval at four separate sites that drain to the bilateral axillary and inguinal lymph node basins. Average dose of 7.7×107 total DC and 8.6×106 p53+ DC.
• P53 specific T cell response to vaccination were observed in 57.1% of all the patients
• A detectable preimmunization level of anti-p53 antibody was observed in 10 out of 22 (45%) and only 3 patients showed a significant increase in the level of anti-p53 antibodies after immunization.
• Adverse events associated with the administration of the vaccine were infrequent and mostly mild; 2 patients had grade 2 adverse events (1 with fatigue, 1 with arthralgia)
• 1 patient achieved partial response (PR), 7 patients achieved stable disease (SD) and 21 patients had progressive disease (PD)
• 1 patient with solid measurements revealed a 60% decreased in the size of all of her measurable lesions.
• The median overall survival of all the patients was 11.8 months from the time of the first vaccine administered.
This study provides clinical support for an emerging paradigm in cancer immune-therapy, wherein optimal use of vaccination might be more effective, not as a separate modality, but in direct combination with chemotherapy.
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Scientific article publishing date : 1/2/2006
Immucura identifier : BSC21_002EN