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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000006
• Date of registration: 03/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: 1E10 anti-idiotype vaccine, metastatic colon, phase II.
• Scientific title: Active specific immunotherapy with 1E10 anti-idiotype vaccine to treat patients with metastatic colon cancer, phase II.
• Date of first enrolment: 19/07/2002
• Target sample size: 40
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000006-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: MD, PhD Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

• Name: MD,PhD Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients of any sex with colon adenocarcinoma phase IV or evolvable metastatic disease upon diagnosis, cyto-histological confirmation of the disease. Patients who have received any first-line onco-specific treatment for the disease and completed such treatment within the last six months. 2. Patient’s consent in writing to participate in the research. 3. Patients over 18 years of age. 4. Patients with a life expectancy of six months or more. 5. Patients with Grade 0 to 2 Performance Status evaluation, in keeping with WHO criteria. 6. Clinical laboratory parameters: a.-) Hematopoietic parameters: - Hb: 100g/l, leucocytes: 4 x 109cells/l, granulocytes: 2x109 cells/l, platelets: 100 x 109cells/ l. b.-) Liver (not exceeding the normal upper limit by three times), bilirubin: 17mol/l (LSN), ALAT: 40U/l (LSN), ASAT: 40U/l (LSN), alkaline phosphatase: 279U/l c.-) Kidney: serum creatinine: 132 ?mol/l.
Exclusion criteria: 1. Patients who, before trial inclusion, have received first-line onco-specific therapy for metastatic disease, which is not established in national and international oncological standards, or have completed such treatment over 6 months prior to therapy. 2. Pregnancy or breastfeeding. 3. Patients with brain metastasis or a previous history of demyelinating or degenerative diseases of the peripheral or central nervous system. 4. Patients with appropriately treated malignant diseases, except in situ cervix carcinoma or skin cancer (other than melanoma). 5. Patients with acute or chronic infectious diseases. 6. Patients with acute allergic conditions or history of severe allergic reactions. 7. Patients with autoimmune diseases or decompensated chronic diseases. 8. Patients with local relapse or peritoneal carcinomatosis as the only lesion site. 9. Patients with intra-abdominal ganglia as the only site of metastatic location without cyto-histological confirmation.

Age minimum: 19 years
Age maximum: No limit
Gender: Both

Health Condition(s) or Problem(s) studied

Colon adenocarcinoma phase IV or evolvable metastatic disease

Intervention(s)

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 posterior surface of leg.

Primary Outcome(s)

Survival time. Measuring time: 16 months

Secondary Outcome(s)

Immune humoral response, toxicity and clinical response. Measuring time: 16 months

Secondary ID(s)

CRD-EC052

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable