h-R3 MAb combined with radio chemotherapy to treat non-surgical esophagus tumors of epithelial origin.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000014
• Date of registration: 29/12/2010
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: h-R3 MAb combined with radio chemotherapy to treat non-surgical esophagus tumors of epithelial origin.
• Scientific title: Clinical trial, phase II. Evaluation of the antitumoral effect of monoclonal antibody h-R3 combined with radio chemotherapy to treat non-surgical esophagus tumors of epithelial origin.
• Date of first enrolment: 14/12/2005
• Target sample size: 68
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000014-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

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 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 < 75 years. 6. General health condition ECOG < 2 (Karnosfsky > 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: 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.

Age minimum: 19 years
Age maximum: 74 years
Gender: Both

Health Condition(s) or Problem(s) studied

Non-surgical malignant esophagus tumors.

Intervention(s)

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/m2, by continuous infusion, 4 cycles on weeks 2, 6, 10 and 14, the 2nd day in every week. - 5-Fluorouracyl (5-FU) 750 mg/m2 by continuous infusion, 4 cycles on weeks 2, 6, 10 and 14, on days 2 to 5 every week. Radiotherapy: 1.8 to 2.0 Gy daily, on weeks 2, 3, 4, 5 and 6, five days a week, totaling 25 sessions until reaching 45 to 50 Gy. TheraCIM h-R3 MAb 200 mg of h-R3 MAb by intravenous route (antecubital vein), in 250ml volume (completed with saline solution) in rapid infusion (30 minutes), 6 administrations, on weeks 1, 2, 3, 4, 5 and 6, the 1st day every week. Group II. Control This group will be on radio chemotherapy, just as the previous group.

Primary Outcome(s)

Objective antitumoral response, life expectancy over six months. Measuring time: 4 months.

Secondary Outcome(s)

Quality of life, HAMA response, time of duration of objective antitumoral response. Measuring time: 12 months.

Secondary ID(s)

IIC RD-EC075

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable