hR3 monoclonal antibody combined with chemoembolization in mestatatic liver treatment.

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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:

Toxicological evaluation and antitumoral effect of hR3 monoclonal antibody combined with chemoembolization in metastatic liver treatment.

Secondary indentifying numbers:

IIC RD-EC085

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 :

18/08/2006

Reference number:

1467/05.007.06B

Principal investigator

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

First name:

Julio Cesar Hernandez, MD. 2nd degree Specialist in Internal Medicine.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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:

Not applicable

Research ethics committees:

Center of Researches Surgical-Medical (CIMEQ), January 30, 2006.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

29/09/2006

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:

Primary malignant colon and breast lesion and metastatic liver lesions.

Intervention(s):

The trial will include 4 MaB dose levels, 3 patients at each. Dose to be evaluated: 50mg, 100mg, 200mg and 400mg of hR3. All patients will be subjected to chemoembolization and TheraCIM hR3 Humanized Monoclonal Antibody. Only one single MAb dose will be administered in combination with 5-Fluoracyl, Lipiodol and Gel Foam intra-arterially.

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 for over 1 month. Measuring time: 3 months.

Key secondary outcomes:

Toxicity profile, objective antitumoral response duration and dose-effect relation. Measuring time: 3 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:

18 years

Maximum age:

74 years

Inclusion criteria:

1) Patients diagnosed with chemoembolization-sensitive metastatic liver lesions. 2) Non-resectable tumor. 3) Capacity to understand the trial and readiness to sign the informed consent document. 4) Patients with measurable lesions (in, at least one dimension: greater diameter), using conventional techniques (CAT and US). 5) Age >=18 and under 75. 6) General ECOG Condition <= 2 (Karnofsky >= 60%). 7) Mean life expectancy over 1 month. 8) Patients with organs and bone marrow working well, in keeping with the following parameters: leucocytes: >= 2,000 x 109/l, hemoglobin: >= 9 g/de, absolute neutrophil counting: >= 1,500/ul, platelet counting: >= 50,000/ul, creatinine clearing: <= 60 ml/min/1.73m2 (For patients whose creatinine values are higher than normal, as established by the institution). Electrocardiogram: without any alterations in auricular-ventricular conduction. 9) Reproductive-age female patients should be pregnancy-test negative and use appropriate contraceptives like IU devices, hormonal based contraceptives, barrier methods, or tubal ligation. Male patients should use contraceptive methods while on treatment. 10) Patients who have been on appropriate treatment for skin carcinoma or in situ uterus carcinoma.

Exclusion criteria:

1) Terminally ill patients with life expectancy lower than 1 month. 2) Patients on any other product under trial. 3) Patients who have been suffering from allergy attributed to chemical or biological compounds similar to TheraCIM hR3 MAb or the chemotherapy used for the trial. 4) Patients with intercurrent, uncontrolled diseases, including active infections, symptomatic congestive heart failure, unstable angina pectoris, and mental or social diseases limiting adherence to clinical trial requirements. 5) As a result of potential and unknown adverse events in infants, women breastfeeding will not be included in the clinical trial. 6) Patients with demonstrable non-hepatic metastasis. 7) Patients with hepatic encephalopathy. 8) Patients with biliary obstruction. 9) Patients with hepatofugal portal flow or total obstruction of portal vein. 10) Tumor size exceeding liver size by 50%. 11) Patients with serum bilirubin over 85 umol/L. 12) Patients with TGP over 100 UI/l.

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:

Other

Other design:

Secuential

Phase:

1-2

Target sample size:

15

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:

Mayra

Last Name:

Ramos Suzarte

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

Country:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

mayra@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:

Mayra

Last Name:

Ramos Suzarte

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

Country:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

mayra@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:

RPCEC00000023

Date of Registration in Primary Registry:

2010-12-29

Record Verification Date:

2008-01-17 19:00

Link to the spanish version:

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Registered Trials

Registration process

hR3 monoclonal antibody combined with chemoembolization in mestatatic liver treatment.

About the RPCEC

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