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

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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:

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.

Secondary indentifying numbers:

IIC RD-EC075

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 :

15/04/2005

Reference number:

749/05.035.04B

Principal investigator

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

First name:

Nery

Last name:

González Lazo

Medical Specialty :

MD. 2nd degree Specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29 Street, corner F, Plaza

City:

Havana

País:

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:

Havana City, Hermanos Ameijeiras Hospital, Mayte Lima Perez, MD. 1st degree Specialist in Oncology.

Santiago de Cuba, Conrado Benitez Hospital, Orlando Carreras, MD. 2nd degree Specialist in Oncology.

Pinar del Rio, III Congreso Hospital, Humberto Frias, MD. 1st degree Specialist in Gastroenterology.

Matanzas, José Ramon Lopez Tabrane Hospital, Jesus Pinto Contrera, MD. 1st degree Specialist in Oncology

Research ethics committees:

National Institute of Oncology and Radiobiology (INOR), July 19, 2006

Hermanos Ameijeiras Hospital, July 19, 2006

Conrado Benitez Hospital, November 13, 2006.

III Congreso Hospital, June 6, 2006

Jose Ramon Lopez Tabrane Hospital, October 18, 2006

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

14/12/2005

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:

Non-surgical malignant esophagus tumors.

Health condition(s) code:

Esophageal Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Biliary Tract Neoplasms

Digestive System Neoplasms

Esophageal Diseases

Gastrointestinal Diseases

Digestive System Diseases

Neoplasms, Glandular and Epithelial

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.

Intervention code:

Antibodies, Monoclonal, Humanized

Radiotherapy

Drug Therapy, Combination

Cisplatin

Fluorouracil

Antibodies, Monoclonal

Infusions, Intravenous

Administration, Intravenous

Intervention keyword:

TheraCIM hR3

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):

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

Key secondary outcomes:

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

19 years

Maximum age:

74 years

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.

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:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

68

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

Specialty:

Specialist in Biochemistry

Affiliation:

Center of Molecular Immunology(CIM)

Postal Address:

216 Street, corner 15, Atabey, Playa

City:

Havana

País:

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

Specialty:

Specialist in Biochemistry

Affiliation:

Center of Molecular Immunology(CIM)

Postal Address:

216 Street, corner 15, Atabey, Playa

City:

Havana

País:

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:

RPCEC00000014

Date of Registration in Primary Registry:

2010-12-29

Record Verification Date:

2016/12/09

Next update date:

2017/12/09

Link to the spanish version:

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

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