hR3 monoclonal antibody combined with chemoembolization in mestatatic liver treatment.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000023
• Date of registration: 29/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: hR3 monoclonal antibody combined with chemoembolization in mestatatic liver treatment.
• Scientific title: Toxicological evaluation and antitumoral effect of hR3 monoclonal antibody combined with chemoembolization in metastatic liver treatment.
• Date of first enrolment: 29/09/2006
• Target sample size: 15
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000023-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Treatment Other design features: Secuential

Countries of recruitment

Cuba

Contacts

• Name: Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 74 years
Gender: Both

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.

Primary Outcome(s)

Survival for over 1 month. Measuring time: 3 months.

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-EC085

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable