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

Phase 2

• Conditions: Colon adenocarcinoma phase IV or evolvable metastatic disease; Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

• Registration Number: RPCEC00000006
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time. Measuring time: 16 months

Secondary Outcome Measures

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