Revisions for 1E10 anti-idiotype vaccine, metastatic colon, phase II. | Registro Público Cubano de Ensayos Clínicos

Revision of 20 January 2017 - 12:35pm:

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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

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

Secondary indentifying numbers:

CRD-EC052

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Government funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

17/08/2001

Reference number:

40051

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Neri

Last name:

González Lazo

Medical Specialty :

2nd Degree Specialist in Gastroenterology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29, corner Street F, Plaza

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78382578

Email address:

dinor@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, "Hermanos Ameijeiras" Clinical-Surgical Hospital, Dr. José María Perez Melo, 1st Degree Specialist in Oncology

Havana, Surgical Medical Research Center (CIMEQ), Dr. Mauricio Catala Ferrer, 2nd Degree Specialist in Oncology

Research ethics committees:

National Institute of Oncology and Radiobiology (INOR), December 27, 2000.

Hermanos Ameijeira Hospital, November 27, 2000

Surgical Medical Research Center (CIMEQ), July 7th, 2001

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

19/07/2002

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Colon adenocarcinoma phase IV or evolvable metastatic disease

Health condition(s) code:

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Diseases

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.

Intervention code:

Leucovorin

Fluorouracil

Vaccines

Antibodies, Anti-Idiotypic

Antibodies

Surgical Procedures, Operative

Antineoplastic Combined Chemotherapy Protocols

Infusions, Intravenous

Injections, Intradermal

Intervention keyword:

Oxaliplatino Irinotecan 1E10 anti-idiotype vaccine

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Survival time. Measuring time: 16 months

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Specialty:

Medical Second Degree Specialist in Clinical Biochemistry

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

16040, Box 11600

Telephone:

(537) 271-7933

Email :

amparo@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Specialty:

Medical Second Degree Specialist in Clinical Biochemistry

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

16040, Box 11600

Telephone:

(537)271-7933

Email :

amparo@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000006

Date of Registration in Primary Registry:

2010-12-03

Record Verification Date:

2017/01/20

Next update date:

2018/01/20

Link to the spanish version:

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20 January 2017 - 12:35pm by lazara		20 January 2017 - 12:35pm by lazara
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1E10 anti-idiotype vaccine, metastatic colon, phase II.

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