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1.  Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer 
Biologics : Targets & Therapy  2008;2(3):555-561.
The purpose of this study was to compare chemotherapy-naive patients with stage IV nonsmall cell lung cancer patients treated with chemotherapy or chemoimmunotherapy. We tested doxetacel plus cisplatinum as chemotherapy protocol. An immunomodulatory adjuvant system was added as chemoimmunotherapy to the previously mentioned protocol. This system contains three well-known and complementary conditioners of protective immune-responses: cyclophosphamide low-dose, granulocyte macrophage-colony stimulant factor and magnesium silicate granuloma. Eighty-eight patients were randomly assigned to receive every 3-weeks one of the treatments under comparison. Patients received four cycles of treatment unless disease progression or unacceptable toxicity was documented. The maximum follow-up was one year. In each arm, tumor response (rate,duration), median survival time, 1-year overall survival, safety, and immunity modifications were assessed. Immunity was evaluated by submitting peripheral blood mononuclear cells to laboratory tests for nonspecific immunity: a) phytohemaglutinin-induced lymphocyte proliferation, b) prevalence of T-Regulatory (CD4+CD25+) cells and for specific immunity: a) lymphocyte proliferation induced by tumor-associated antigens (TAA) contained in a previously described autologous thermostable hemoderivative. The difference (chemotherapy vs. chemoimmunotherapy) in response rate induced by the two treatments (39.0% and 35.0%) was not statistically significant. However, the response duration (22 and 31 weeks), the median survival time (32 and 44 weeks) and 1-year survival (33.3% and 39.1%) were statistically higher with chemoimmunotherapy. No difference in toxicity between both arms was demonstrated. A switch in the laboratory immunity profile, nonspecific and specific, was associated with the chemoimmunotherapy treatment: increase of proliferative lymphocyte response, decrease of tolerogenic T-regulatory cells and eliciting TAA-sensitization.
PMCID: PMC2721394  PMID: 19707385
lung cancer chemotherapy; lung cancer chemoimmunotherapy; cancer vaccine; immunomodulatory cancer treatment; immunotherapy adjuvants; cancer therapy
2.  Advanced ovarian cancer: Vaccination site draining lymph node as target of immuno-modulative adjuvants in autologous cancer vaccine 
Biologics : Targets & Therapy  2007;1(2):173-181.
Tumor as source of tumor associated antigens (TAA) and sentinel lymph node (SLN) configure the first interaction between the malignant disease and the patient’s immune system. As consequence of this interaction, a local immune response is elicited inside the SLN. Tumor’s cytokines reach the SLN conditioning its cellular microenvironment to produce local permissive immune responses. This local tolerogenic immunity is decisional because it starts a systemic also permissive immunity. The tumor progresses.
To counteract this mechanism, we have designed a medical procedure to create an immunotherapeutic site (ITS) that reproduces, distantly from the tumor, a TAA source and a draining lymph node but with a cellular microenvironment conditioned to promote local protective instead of permissive immune responses. Due to ITS decisional role, this local protective immunity starts a systemic anti-tumoral immune response.
In progressive ovarian cancer, we tested an ITS using the autologous thermostable hemoderivative-cancer vaccine as TAA source and granulocyte macrophage-colony stimulant factor plus etoposide, injected both at the vaccination site, as conditioner of the draining lymph node cellularity. The immunophenotyping of lymph node cell populations showed that ITS acquired a locally protective immune profile T-regulatory-cells/activated-antigen presenting-cells and systemically increased the antiprogressive effect of the tested vaccine.
PMCID: PMC2721301  PMID: 19707327
autologous vaccine; ovarian cancer; cancer vaccine; cancer immunotherapy; immunotherapy adjuvants

Results 1-2 (2)