Study of the mechanism of action of Nimotuzumab in patients with head and neck tumors

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.

Acronym of Public Title:

PL013

Scientific title:

Use of monoclonal antibody Nimotuzumab and radio-chemotherapy in the treatment of patients with locally advanced head and neck cancer

Acronym of Scientific Title:

PL013 N-CRT-CC

Secondary indentifying numbers:

PL013

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Ivan

Last name:

Cuevas Veliz

Medical Specialty :

Second grade specialist in oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

Calle 29 Esq. F, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78369209

Email address:

quimioexp@infomed.sld.cu [1]

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,National Institute of Oncology and Radiobiology, Maria del Carmen Barroso, MD. Second grade specialist in oncology

Research ethics committees:

National Institute of Oncology and Radiobiology, May 13th, 2013

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

20/03/2014

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:

Locally advanced head and neck epithelial tumors

Health condition(s) code:

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Carcinoma, Squamous Cell

Receptor, Epidermal Growth Factor

Intervention(s):

Experimental group: RadioChemotherapy + Anti-EGFR mAb Nimotuzumab at 200 mg intravenously. The Nimotuzumab will have an induction phase, once a week for 8 weeks during radio-chemo and, a maintenance phase where the Nimotuzumab will be received every 21 days until deterioration of the patient's physical state, toxicity Severe or rejection of the patient.

Intervention code:

Antibodies, Monoclonal, Humanized

Chemoradiotherapy, Adjuvant

Antineoplastic Agents

Antibodies, Monoclonal

Administration, Intravenous

Intervention keyword:

Nimotuzumab

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):

Measurement of Epidermal Growth Factor Receptor-EGFR-specific T cells (The method is based on the ELISPOT test. The technique measures secretion of cytokines related to the activation of cytotoxic T lymphocytes following stimulation of peripheral blood mononuclear cells with peptides derived from the antigen). Measurement time: 12 months. Overall survival (Time from recruitment until death from any cause). Measurement time: 3, 6, 9 and 12 months.

Key secondary outcomes:

Response to treatment Objective response (measured by RECIST criteria according to Complete Response, Partial Response, Stable Disease, Progression). Measurement time: at baseline, 3, 6, 9 and 12 months. Related to Safety Adverse Events-AE (Type of AE (AE description), Intensity of AE (Light, Moderate, Severe, Very Severe, Event related Death), Causality relationship (Very likely, Probable, Possible, Unlikely, Uncontrolled, Unclassifiable), Applied Treatment (None, Medication, Surgical Procedure, Transfusion, Other), Event Result (Recovered, Continued, Unknown, Death due to event)). Measurement time: at baseline, 3, 6, 9 and 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:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients with epithelial tumors of the head and neck, confirmed by histopathology. 2.Evaluated in stages III or IV (advanced locoregional disease, non-operable). 3. That they have not previously received any oncoespecific treatment for the C and C lesion and that they are taxed on radiochemotherapy at the time of inclusion. 4. Patients with measurable lesions, defined as those that can be accurately measured in at least one dimension (refers to the largest diameter) and have a diameter ≥20 mm using conventional techniques (PET, CT, NMR, Rx) Or ≥10 mm using spiral CT. 5. Age ≥18 years. 6. Overall state according to ECOG ˃2 (Karnofsky greater than 60%). 7. Life expectancy ˃6 months. 8. Patients who have normal functioning of organs and bone marrow defined by the following parameters: • Leukocytes ≥3000/ L • Absolute neutrophil count ≥ to 1500/L • Platelet count ≥ 100,000/L • Total bilirubin: Within normal limits • TGP and TGO ≤2.5 times the institutional upper normal limit • Creatinine: Within normal limits 9. Female patients of childbearing potential should have a negative pregnancy test and should use appropriate contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation. 10. Patients who have signed informed consent

Exclusion criteria:

1. Pregnant or lactating women. 2. Patients of childbearing potential who are not using an adequate method of contraception. 3. Patients who are receiving another drug under investigation. 4. Patients with a history of allergy to compounds of chemical or biological composition similar to nimotuzumab. 5. Patients treated with MAB egor / 3. 6. Patients unable to sign informed consent due to psychiatric problems or other medical problems. 7. Patients with uncontrolled intercurrent diseases including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illness. 8. Patients with previous neoplasias. May include those patients who have received adequate treatment for carcinomas of the skin or carcinoma in situ of the uterus.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

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:

Zaima

Last Name:

Mazorra Herrera

Specialty:

Biochemistry

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

ZP 16040, Box 11600

Telephone:

+53-72717933 Ext 3399

Email :

zaima@cim.sld.cu [2]

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:

Zaima

Last Name:

Mazorra Herrera

Specialty:

Biochemistry

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

ZC 16040, Box 11600

Telephone:

+53-72717933 Ext 3399

Email :

zaima@cim.sld.cu [2]

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:

RPCEC00000241

Date of Registration in Primary Registry:

17/02/2017

Record Verification Date:

2017/02/17

Next update date:

2018/02/17

Link to the spanish version:

Click here [3]