Non-surgical malignant esophagus tumors.
Conditions
Interventions
Patients will be randomly assigned to 2 treatment groups. Group I. Vaccine This group will receive radio chemotherapy + TheraCIM h-R3 MAb, under the following scheme: Chemotherapy: - Cisplatin 75 mg/m
Antibodies, Monoclonal, Humanized
Radiotherapy
Cisplatin
Fluorouracil
Antibodies, Monoclonal
Administration, Intravenous
Sponsors
Center of Molecular Immunology(CIM)
Eligibility
Sex/Gender
All
Age
19 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Patients with non-surgical esophagus tumors of epithelial origin in stages III or IV, located in the following portions of the esophagus: 1- Cervical esophagus: it begins at the lower edge of the cricoid cartilage and ends at the thoracic inlet (suprasternal fossa), 18cm from ICS. 2- Intrathoracic esophagus: a) Upper thoracic portion: from the thoracic inlet (suprasternal fossa) to the trachea bifurcation, 24cm from ICS. b) Middle thoracic segment: it is approximately half of the esophagus, between the trachea bifurcation and the esophagus-gastric join, approximately 32 cm from ICS. 2. Patients without any treatment who are eligible for radio chemotherapy treatment at the time of inclusion. 3. Capacity to understand the study and readiness to sign the informed consent document. 4. Patients with measurable lesions, (in, at least, one dimension: greater diameter) with a diameter greater than or equal to 20mm using conventional techniques (CAT, X rays, US) or greater than or equal to 10mm using helical CAT. 5. Age > 18 and 60%). 7. Life expectancy over 6 months. 8. Patients with organs and bone marrow working normally, defined by the following parameters: leucocytes >3,000/ul, hemoglobin >=9 g/L, absolute neutrophil counting >1,500/ul, platelets >100,000/ul, TGP/TGO 60 ml/min/1.73 m2 for patients with creatinine values higher than normal value, as established by the institution. 9. Reproductive-age females should have a negative pregnancy test and should use appropriate contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation. Males should use contraceptive methods during treatment. 10. Patients who had received appropriate treatment for skin carcinoma or in situ uterus cancer can also be included.
Exclusion criteria
Exclusion criteria: 1. Patients with esophageal tumors in the inferior thoracic portion (distal half of the esophagus, between the tracheal bifurcation and the esophagus-gastric join, approximately 40cm from ICS). 2. Patients on another product under research. 3. Patients with allergy history attributed to chemical or biological compounds similar to TheraCIM h-R3 monoclonal antibody or the chemotherapy used in the study. 4. Patients previously treated with murine monoclonal antibodies (for example, ior egf/r3). 5. Patients with uncontrolled intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric or social diseases restricting compliance with clinical trial requirements. 6. Breastfeeding should be interrupted after patients are included in the clinical trial, due to potential and unknown adverse events for infants. 7. Patients with previous malignant neoplasias, except patients who received appropriate treatments for skin carcinoma or in situ uterus carcinoma. 8. Patients with brain metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective antitumoral response, life expectancy over six months. Measuring time: 4 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, HAMA response, time of duration of objective antitumoral response. Measuring time: 12 months. | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos Suzarte
Center of Molecular Immunology(CIM)
Outcome results
None listed