Effectiveness and Safety of Nimotuzumab for the treatment of patients with glioma 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:

Evaluation of the Effectiveness and Safety of Monoclonal Antibody HR3(Nimotuzumab)for the treatment of patients with high grade glioma tumors.

Secondary indentifying numbers:

IIC RD-EC0114

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology

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:

Trials notification

Regulatory instance:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Notification date :

19/09/2008

Reference number:

04-076-08B

Principal investigator

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

First name:

.Javier

Last name:

Figueredo

Medical Specialty :

Neurosurgery

Affiliation:

Centre of Clinical and Surgical Research (CIMEQ)

Postal address:

216 Street and 11b. Siboney, Playa.

City:

Havana

País:

Cuba

Zip Code:

12100

Telephone:

+53-8581000

Email address:

javierfm@infomed.sld.cu

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,MD.Silvia Noema Salva.Second degree specialist in Neurosurgery. Havana City,Nacional Institute of Oncology and Radiobiology,MD.Daysi Chi Ramirez,First degree specialist in Neurology,Second degree specialist in Oncology. Havana City,Carlos J.Finlay Hospital,MD.Víctor Dubois.Second degree specialist in Neurosurgery. Havana City,Calixto García Universitary Hospital,MD.Maria Teresa Solomon Cardona,First degree specialist in Neurosurgery. Pinar del Río,Congress Three Hospital,MD.Bárbara Iglesias Hernández.First degree specialist in Oncology. Matanzas,José R.López Tabranes Hospital,MD.Rafael Guerra Sanchez,First degree specialist in Neurosurgery. Villa Clara,Arnaldo Milián Hospital,MD.Jose E.Vaquer Fernandez.First degree specialist in Neurosurgery. Villa Clara,Celestino Hernández Robau Universitary Hospital,MD.Julio Orlando Hernandez Cruz.First degree specialist in Oncology. Camaguey,Maria Curié Oncology Hospital,MD.Carolina Toledo Jimenez,First degree specialist in Oncology. Holguín,Lucía Iñiguez Landin Surgical-Medical Hospital,MD.Julio Cesar Selva Infantes.Second degree specialist in Neurosurgery. Santiago de Cuba,Saturnino Lora Torres Surgical-Medical Hospital,MD.Rafael Domínguez Peña.First degree specialist in Neurosurgery.

Havana City, Nacional Institute of Oncology and Radiobiology, MD.Daysi Chi Ramirez,First degree specialist in Neurology,Second degree specialist in Oncology.

Havana City, Carlos Finlay Hospital, MD.Víctor Dubois. Second degree specialist in Neurosurgery.

Havana City, Calixto García Universitar y Hospital, MD. Maria Teresa Solomon Cardona, First degree specialist in Neurosurgery.

Pinar del Río, Congress Three Hospital, MD.Bárbara Iglesias Hernández.First degree specialist in Oncology.

Matanzas, José R.López Tabranes Hospital, MD. Rafael Guerra Sanchez, First degree specialist in Neurosurgery.

Villa Clara, Arnaldo Milián Hospital, MD. Jose E. Vaquer Fernandez.First degree specialist in Neurosurgery

Villa Clara, Celestino Hernández Robau Universitary Hospital, MD.J ulio Orlando Hernandez Cruz.First degree specialist in Oncology.

Camagüey, Maria Curié Oncology Hospital, MD. Carolina Toledo Jimenez, First degree specialist in Oncology.

Holguín, Lucía Iñiguez Landin Surgical-Medical Hospital, MD. Julio Cesar Selva Infantes. Second degree specialist in Neurosurgery.

Santiago de Cuba, Saturnino Lora Torres Surgical-Medical Hospital, MD.Rafael Domínguez Peña. First degree specialist in Neurosurgery.

Research ethics committees:

Havana City,Center of Surgical and Medical Research, July 1,2008.

Havana City, Hermanos Ameijeiras Hospital, September 15,2008.

Havana City, Nacional Institute of Oncology and Radiobiology, June 29,2009.

Havana City, Carlos J.Finlay Hospital, January 22,2009.

Havana City, Calixto Garcia Universitary Hospital, May 14,2009.

Pinar del Río, III Congreso Hospital, June 30,2008.

Matanzas, José R.López Tabranes Hospital, April 22,2009.

Villa Clara, Arnaldo Milián Castro Hospital, November 14,2008.

Villa Clara, Universitary Hospital.Celestino Hernandez Robau, March 16,2009.

Camaguey,Maria Curié Hospital, October 13,2008.

Holguin, Lucia Iñiguez Landin Hospital, September 29, 2008.

Santiago de Cuba, Saturnino Lora Hospital, July 29,2008.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

29/09/2008

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:

High grade glioma tumors

Intervention(s):

Nimotuzumab: 200 mg intravenous (antecubital vein) in a volume of 250 ml (complete with saline) infusion for one hour. Induction Phase: 200mg (once per week) for 6 weeks. If the patient is newly diagnosed, this treatment will be received concomitant with radiation therapy (RT). If after 15 days of surgery, is not possible to begin the RT, treatment with Nimotuzumab will begin, and the induction phase will continue until the end of RT. Radiotherapy (RT):1.8-2Gy daily, split into 5d/week (Monday-Friday). Total dose: between 50 and 60Gy for 5-6 weeks. Maintenance and consolidation phase: One time every 14 days until the patient's deterioration from the disease or toxicity not tolerated.

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):

Global Survival Time (in months) from inclusion date to death or last news. Measurement time: From the inclusion date to the date of death or last news date.

Key secondary outcomes:

Adverse Events (AE). Measuring Time: in every administration of the product. It is compound by: -Description of AE (name of AE) -Intensity of AE (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Danger to life, Grade 5: Death) -Causation of AE (very likely causality, likely Causality, possible Causality, not related, Unknown) Objective antitumor response evaluated using MacDonald criteria (Complete response, partial response, progressive disease, stable disease). Measurement Time: Prior to inclusion in the clinical trial, at week 8 and every 3 months to 24 months. Progression-free survival (PFS). Time between the start of treatment at the date of clinical progression or imaging/last scheduled visit when there is news of the patient/or date of death. Measuring Time: since the start of treatment at the last scheduled visit when there is news of the patient/or date of death.

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 glials tumors grade III or IV confirmed by pathology techniques,which at the time of inclusión are candidates for onco-specific treatment or patients with the same diagnosis who are relapsed. 2.Age = 18 years of both sexes. 3.General health status according to Karnofsky index = 50. 4.Laboratory parameters within normal limits defined as:Hematopoietic:Hemoglobin = 9 g/L,total leukocytes count = 3 x 109 cells/L,platelets = 100 x 109/L Hepatic:hepatic function within 2.5 times upper limit of normal and without liver diseases demonstrated by TGP and TGO alkaline phosphatase. 5.Patients express written voluntary entry into the study by signing the document informed consent. 6.Patients of childbearing age should have a negative pregnancy test and used effective methods of contraception such as IUDs,hormonal contraceptives, barrier method or tubal ligation.

Exclusion criteria:

1.Pregnancy or lactation. 2.Patients with a concomitant second tumor. 3.Submit a chronic disease associated in decompensated phase(heart disease,diabetes,hypertension). 4.History of hypersensitivity to other similar product. 5.Severe acute allergic states. 6.Fever. 7.Severe septic processes.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Phase:

Target sample size:

Inclusion of 3 years.

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:

Giselle

Last Name:

Saurez Martínez

Specialty:

Integral General Medicine and Pharmacology

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926 e/19 and 21 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271 50-57 Ext.111

Email :

giselle@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:

Giselle

Last Name:

Saurez Martínez

Specialty:

Integral General Medicine and Pharmacology

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926 e/19 and 21 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271 50-57 Ext.111

Email :

giselle@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:

RPCEC00000087

Date of Registration in Primary Registry:

2009-09-18

Record Verification Date:

2015/07/17

Next update date:

2016/07/17

Link to the spanish version:

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Effectiveness and Safety of Nimotuzumab for the treatment of patients with glioma tumors

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