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Her1 vaccine in metastatic colon and prostate cancer

ABSTRACT: Interventions: All patients included in the study will be treated with the HER1 vaccine. Dose: Initially 2 dose levels (400µg and 800µg) will be opened in each stratum (prostate and colon). In the event of closure of both dose levels due to some stop criteria, another dose (1200 µg) will be opened. Route of administration: Intramuscular. Treatment frequency: Every 14 days during the first five administrations (approximately 2 months) and subsequently, every 28 days for the remaining ten immunizations, until discontinuation for any of the reasons provided for in the research protocol or upon completion of 12 months of treatment. . The treatment period will be 336 days, approximately 12 months.;ErbB Receptors;Vaccines;Injections, Intramuscular;HER1, therapeutic vaccine Primary outcome(s): Proportion of patients with serious adverse events with a causal relationship (according to CTCAE criteria and causality criteria: SAE with very probable, probable or possible causation). Measurement time: at all times of administration of the research product. Study Design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment

DISEASE(S): Gastrointestinal Neoplasms,Intestinal Diseases,Digestive System Diseases,Genital Neoplasms, Male,Prostate And Colon Cancer,Prostatic Neoplasms,Gastrointestinal Diseases,Prostatic Diseases,Male Urogenital Diseases,Colorectal Neoplasms,Genital Diseases, Male,Urogenital Neoplasms,Prostatic Neoplasms, Castration-resistant,Intestinal Neoplasms,Colonic Neoplasms,Digestive System Neoplasms,Colonic Diseases

PROVIDER: 94899 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Despite substantial investments, tuberculosis remains one of the biggest challenges in public health. DNA-immunotherapy is increasingly being suggested as a possibility to assist conventional treatment of tuberculosis. This strategy could allow treatment to be more efficient, faster and with advantages and modulate the host immune response, as demonstrated by our group with DNAhsp65 vaccine (Silva, Bonato et al., Gene Therapy, 2005). Based on this evidences, we performed a microarray assay to stydy the functional effects of DNAhsp65 immunotherapy associated with conventional chemotherapy in murine experimental tuberculosis. Briefly, we used a murine model of tuberculosis treatment compost by DNAhsp65 vaccine, or rifampicin and isoniazid or both therapies combined and performed a comprehensive analysis of its effects on gene expression of hostM-bM-^@M-^Ys lung . Female BALB/c mice,8 weeks old, were inoculated with 1.0 M-CM-^W 10e5 viable bacilli of Mycobacterium tuberculosis H37Rv strain by the intra-tracheal route in a level III bio-safety room facility (day 0). They were segregated in four groups, described below, with three animals each one. Control M-bM-^@M-^S just infected and not treated. Immunotherapy - Thirty days after challenge, 50 M-NM-<g of plasmid with DNA-insert (DNAhsp65) was administered by intramuscular injection in 50 M-NM-<L of 25% saccharose solution in saline into each quadriceps muscle, in four occasions, and at 10-days intervals, performing a final dose of 400 M-NM-<g of plasmid DNAhsp65 per animal. Control infected mice received saline. Chemotherapy - Thirty days after infection, animals were treated with water solution of isoniazid (25 mg/Kg, Sigma-Aldrich, St. Louis, MO, USA) and rifampicin (20 mg/Kg, Sigma-Aldrich, St. Louis, MO, USA) daily, during 30 days, by gavage. Control infected mice received the same volume of water. Association - The therapeutical association consists of the both therapeutical approaches, as described above. Ten days after the end of treatments, mice were killed by cervical dislocation under mild anesthesia, and lungs were removed to RNA extraction.

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Her1 vaccine in metastatic colon and prostate cancer

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