Use of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial 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.

Scientific title:

Phase Ib/IIa clinical trial: Use of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial head and neck tumors.

Secondary indentifying numbers:

IIC RD-EC040

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 :

17/06/1999

Reference number:

881/99

Principal investigator

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

First name:

Teresa

Last name:

Cruz Rivero

Medical Specialty :

2nd degree specialist in oncology

Affiliation:

National Institute of Oncology and Radiobiology

Postal address:

29 street corner F, Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78382578

Email address:

email@not.entered [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:

Not applicable

Research ethics committees:

National Institute of Oncology and Radiobiology (INOR), February 3th, 1999

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

09/08/1999

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:

Advanced epithelial head and neck tumors.

Health condition(s) code:

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Intervention(s):

Four levels of MAb hR3 doses Level 1: 50 mg once a week, for 6 weeks (Total doses: 300 mg) Level 2: 100 mg once a week, for 6 weeks (Total doses: 600 mg) Level 3: 200 mg once a week, for 6 weeks (Total doses: 1200 mg) Level 4: 400 mg once a week, for 6 weeks (Total doses: 2400 mg ) During that time, the patient will be on conventional radiant treatment.

Intervention code:

Antibodies, Monoclonal, Humanized

Radiotherapy

Antibodies, Monoclonal

Intervention keyword:

AcMh-R3

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):

Antitumoral effect. Measuring time: 12 months.

Key secondary outcomes:

Adverse reactions and maximum permissible dose. 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:

18 years

Maximum age:

75 years

Inclusion criteria:

1.Patients with epithelial head and neck tumors in oral cavity and mesopharynx, stages III or IV, eligible for radiant treatment. 2.Patients with epithelial head and neck tumors not eligible for surgical treatment or undergoing relapse upon inclusion. 3.EGF-R expression confirmation by immunohistochemistry. 4.Patient’s consent in writing. 5.Age from 18 to 75 years, of both sexes. 6.WHO Performance Status lower than or equal to 2. 7.Six month life expectancy. 8.Clinical laboratory parameters: Hb >10 g/l; total leukocytes over 4 x 109 cells/l; platelets > 100 x 109/L. Liver function within normal limits and/or patients with history of liver condition confirmed by TGP, TGO or alkaline phosphatase. Kidney function: serum creatinine?132 mmol/l.

Exclusion criteria:

1.Non compliance with inclusion criteria. 2.Patients treated with murine R3 MaB. 3.Pregnancy or breastfeeding. 4.Decompensated chronic disease: cardiopathy, diabetes, high blood pressure. 5.History of hypersensitivity to this or any similar product. 6.Fever 7.Severe septic processes. 8.Acute or serious allergic conditions.

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:

Other

Other design:

Dose escalations

Phase:

1-2

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:

Tania

Last Name:

Crombet Ramos

Specialty:

Specialist of 1st Degree in Clinical Immunology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 218

Email :

taniac@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:

Tania

Last Name:

Crombet Ramos

Specialty:

Specialist of 1st Degree in Clinical Immunology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana city

Country:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 218

Email :

taniac@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:

RPCEC00000071

Date of Registration in Primary Registry:

2010-12-17

Record Verification Date:

2008-07-24 20:00

Link to the spanish version:

Click here [3]