Clinical trial, phase II: Evaluation of TheraCIM hR3 MaB combined with chemo- and radio-therapy to treat patients with epithelial tumors in neck of the uterus, stage III.

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:

Secondary indentifying numbers:

IIC RD-EC078

Issuing authority of the secondary identifying numbers:

Center of Molecular Inmununology (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 :

28/01/2006

Reference number:

234/05028.04B

Principal investigator

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

First name:

Juan

Midle name:

Mario

Last name:

Silveira Pablos

Medical Specialty :

2nd degree specialist in oncology.

Affiliation:

National Institute of Oncology and Radiobiology

Postal address:

Calle 29 esquina a 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:

Camaguey, Maria Curie Oncology Hospital, Pedro Daniel Cardoso Rodríguez, MD.1st degree specialist in oncology

Santiago de Cuba, Conrado Benitez Oncology Hospital, Juan Antonio Gutierrez Rodríguez, MD. 1st degree specialist on oncology

Matanzas, Jose Ramon Lopez Tabrane Hospital, Moyra Duquezne Ulacia, MD. 1st degree specialist on oncology

Research ethics committees:

National Institute of Oncology and Radiobiology, June 27,2005.

Maria Curie Oncology Hospital, December 13, 2004.

Conrado Benitez Oncology Hospital, May 14, 2005.

Jose Ramon Lopez Tabrane Hospital, June 14, 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:

30/05/2007

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:

Epithelial tumors in neck of the uterus, stage III.

Health condition(s) code:

Cervical Intraepithelial Neoplasia

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Carcinoma in Situ

Carcinoma

Neoplasms, Glandular and Epithelial

Intervention(s):

Study group: A total of 200mg of TheraCIM hR3 MAb will be administered 9 times, combined with chemo- and radiotherapy. Dose 1. Prior to chemo- and radio-therapy. Dose 2-7. Together with the administration of six week treatment with chemo- and radio-therapy. Dose 8. Alone. Dose 9. First week of brachytherapy. TheraCIM hR3 MAb will in all cases be administered intravenously (antecubital vein), in 250mL of saline solution in infusion, during 30 minutes approximately. Control group: The patients will receive chemotherapy and radiotherapy like the study group.

Intervention code:

Antibodies, Monoclonal, Humanized

Radiotherapy

Drug Therapy

Brachytherapy

Antibodies, Monoclonal

Administration, Intravenous

Intervention keyword:

AcM 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):

Survival, measuring time: 2 years.

Key secondary outcomes:

Antitumoral response, progression time, safety, HAMA response, reduced associated symptoms, measuring time: 3 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

18 years

Maximum age:

70 years

Inclusion criteria:

1) Patients giving their consent in writing to participate in the trial. 2) Female patients with measurable lesions, defined as those that can be exactly measured in one dimension at least (greater diameter) and have a diameter equal to or higher than 20mm, using conventional techniques (abdominal CAT, X rays, US), or higher than or equal to 10mm, using spiral CAT or clinical tests. 3) Patients aged 18 to 70. 4) General condition under ECOG =2. 5) Patients whose organs and bone marrow are working normally, as defined by the following parameters: - Hemoglobin >= 10g/L - Leucocytes >= 4,000/mL- Absolute neutrophil count >= 1,500/mL – Platelet count >= 100,000/L – Total bilirubin: up to 1.5 times the normal value - Total proteins: Within normal limits - TGP and TGO <= 2.5 times the institutional higher normal value – Serum creatinine: Within normal limits, and glomerular filtering based on Cockcrof Formula – Creatinine clearing = (140-age) x weight (kg)/72 x serum creatinine. Following clinical criteria, glomerular filtering will be performed only on patients whose kidney function is thought to be affected. (Normal laboratory values will be in keeping with the technology and equipment available where tests are conducted). 6) Female patients will be included in the study.

Exclusion criteria:

1. Pregnancy or breastfeeding. 2. Patients on another onco-specific drug under research (except EPOCIM and/or LeukoCIM). 3. Patients with history of allergy to chemical and biological compounds similar to the monoclonal antibody under evaluation. 4. Patients with uncontrolled intercurrent diseases, including active infections, symptomatic congestive cardiac failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, and psychiatric diseases. 5. Presence of a second tumor, except patients who have been on appropriate treatment for skin (basal or scaly) carcinomas.

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:

Single Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

148

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:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

mayra@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:

Mayra

Last Name:

Ramos Suzarte

Specialty:

Specialist in Biochemistry

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 224

Email :

mayra@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:

RPCEC00000054

Date of Registration in Primary Registry:

2010-12-27

Record Verification Date:

2008-03-14 20:00

Link to the spanish version:

Click here [3]