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

Active specific immunotherapy with 1E10 anti-idiotype vaccine to treat patients with metastatic colon cancer, phase II.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000006

Enrollment

Registered

2010-12-03

Start date

2002-07-19

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon adenocarcinoma phase IV or evolvable metastatic disease

Interventions

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-

Leucovorin

Fluorouracil

Vaccines

Antibodies, Anti-Idiotypic

Antibodies

Surgical Procedures, Operative

Antineoplastic Combined Chemotherapy Protocols

Infusions, Intravenous

Injections, Intradermal

Oxaliplatino Irinotecan 1E10 anti-idiotype vaccine

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Survival time. Measuring time: 16 months	—

Secondary

Measure	Time frame
Immune humoral response, toxicity and clinical response. Measuring time: 16 months	—

Countries

Cuba

Contacts

Public ContactAmparo Macias Abraham

Center of Molecular Immunology (CIM)

amparo@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026