Primary malignant colon and breast lesion and metastatic liver lesions.
Conditions
Interventions
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
Fluorouracil
Antibodies, Monoclonal
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion 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 = 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival for over 1 month. Measuring time: 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity profile, objective antitumoral response duration and dose-effect relation. Measuring time: 3 months. | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos Suzarte
Center of Molecular Immunology (CIM)
Outcome results
None listed