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1E10 anti-idiotype vaccine, metastatic colon, phase II.

ABSTRACT: Interventions: Onco-specific treatment: -Surgical treatment in resectable tumors (liver, lung), followed by first-line systemic chemotherapy four weeks later. -First-line systemic chemotherapy in non-resectable tumors. First-line chemotherapy: Six cycles every 4 weeks of: - Leucovorine (folinic acid) 20 mg/ m2/ daily, intravenously, for 5 days. Leucovorine will be administered after dilution in 50 cc of a 0.9% sodium chloride solution, intravenously, 20 minutes before 5-FU. - 5-Fluoracyl (5-FU): 375 mg/ m2/ daily, intravenously, for 5 days. The 5-FU will be administered either in a 5% dextrose solution or a 0.9% sodium chloride solution, 500 cc in 24 hour continuous infusion. Schemes containing Oxaliplatino, Irinotecan or a similar drug authorized for this purpose can also be used in combination with those nationally and internationally authorized and regulated. In conjunction with chemotherapy, the following can be administered: - 100 mg Dimenhydrate, either intravenously or in the chemotherapy infusion flask. - 20 mg Metoclopramide, either intravenously or in the chemotherapy infusion flask. Vaccine preparation: Patients will be administered a total of 15 vaccines, beginning 4 weeks after latest onco-specific treatment. The first 5 vaccines will be administered at 14 day intervals, and the other 10 every month until reaching one year immunization. Each vaccine will contain 1 ml of the vaccine preparation, at a 2 mg/ ml concentration of the 1E10 antibody. The total dose will be subdivided into 4 equal sub-doses, administering 250 µl (0.25 ml) at each inoculation site. The 1E10 anti-idiotype vaccine will be intradermally injected. The potential immunization sites are: deltoid region, anterior surface of forearm, provided that no resection has been performed, and posteri;Leucovorin;Fluorouracil;Vaccines ;Antibodies, Anti-Idiotypic;Antibodies ;Surgical Procedures, Operative;Antineoplastic Combined Chemotherapy Protocols;Infusions, Intravenous;Injections, Intradermal;Oxaliplatino Irinotecan 1E10 anti-idiotype vaccine Primary outcome(s): Survival time. Measuring time: 16 months Study Design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment

DISEASE(S): Gastrointestinal Diseases,Gastrointestinal Neoplasms,Intestinal Diseases,Colon Adenocarcinoma Phase Iv Or Evolvable Metastatic Disease,Digestive System Diseases,Colorectal Neoplasms,Intestinal Neoplasms,Digestive System Neoplasms,Colonic Diseases,Colonic Neoplasms

PROVIDER: 2571348 | 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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1E10 anti-idiotype vaccine, metastatic colon, phase II.

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