Study of intensive pediatric pharmacovigilance of nimotuzumab for the treatment of malignant 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.

Acronym of Public Title:

NIMOPED

Scientific title:

Study of intensive pediatric pharmacovigilance of monoclonal antibody nimotuzumab for the treatment of malignant glioma tumors

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM), CIMAB Ministry of Public Health (MINSAP)

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:

Ricardo

Last name:

Cabanas Armada

Medical Specialty :

First degree Specialist in Pediatrics and Second degree Specialist in Oncology

Affiliation:

Juan Manuel Marquez Pediatric Hospital.

Postal address:

Ave. 31 e/. 76 and 100

City:

Havana

Country:

Cuba

Zip Code:

11500

Telephone:

+53-72602860

+53-72609651

Email address:

cabanas@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:

Santiago de Cuba,Children's South Pediatric Hospital,Dr. Manuel Verdecia Jarque. Specialist 1st grade Oncology

Pinar del Río,Children's Pepe Portilla Hospital,Dr. Yosvany bridges Gonzalez. Specialist 1st grade Pediatrics.

Camagüey,Children's Eduardo Agramonte Piña Hospital, Dr. Juan Carlos Arranz. Specialist. 1st grade Pediatrics

Holguín,Children's Octavio del Concepción y la Pedraja Hospital ,Dra. Melba Zaldivar Santiesteban. Specialist 1st grade neurosurgery.

Villa Clara,University Pediatric Hospital Jose Luis Miranda,Dr.Mario Victor Pichs Leon.Specialist 1st grade Oncology

Research ethics committees:

Children's South Pediatric Hospital,December 18, 2012.

Pediatric Pepe Portilla Hospital,January 17 ,2013

Pediatric Eduardo Agramonte Piña Hospital, January 25,2013

Pediatric Octavio del Concepción y la Pedraja Hospital,March 12, 2013.

University Pediatric Hospital Jose Luis Miranda, November 12, 2013.

Pediatric Hospital Juan Manuel Marquez, October 31, 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:

10/02/2006

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:

Malignant gliomas

Intervention(s):

Scheme 1: Surgery + Radiotherapy (54-60 Gy) + Nimotuzumab + Chemotherapy (Cisplatin + Cyclophosphamide, procarbazine; Carboplatin + Etopoxide). Scheme 2: Surgery + Radiotherapy (54-60 Gy) + Nimotuzumab. Scheme 3: Nimotuzumab (monotherapy). Scheme of Nimotuzumab: Induction phase: Once a week for 6 weeks, by intravenous infusion (IV), 3060 minutes, at a dose of 150 mg/m2 of body surface (SC), (vi al 50mg/10 mL),diluted in 250mL of Sodium Chloride. Maintenance and consolidation phase: 150 mg/m2 doses of Nimotuzumab IV, diluted in 250mL of Sodium Chloride, every 15 days. The treatment will be maintenance until to the deterioration of the disease (KPS/Lansky < 40%), not tolerate toxicity or to discretion of the doctor. It allows the combination of Nimotuzumab with other onco-specific therapies, or as monotherapy, according to the standard of the institution.

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):

Serious Adverse Events with causal relationship with the Nimotuzumab (Recorded serious AE with definitive, very likely or likely causality relationship with the use of the Nimotuzumab). Measurement time: up to 2 years of follow-up after 1 dose of the monoclonal.

Key secondary outcomes:

Number of doses received (total number of doses received by patient). Measurement time: up to 2 years. Occurrence of any Adverse Events (AE) (Yes, No). Measurement time: up to 24 months of follow-up after 1 dose of the monoclonal. - AE description (type of AE notified) - AE intensity (Common Terminology Criteria for Adverse Events, CTCAE). - AE duration (date between the start and the completion of AE). - Causal relationship (Very likely, Likely, Possible, Unlikely, Unrelated, Not evaluable /no classifiable) Overall survival (Duration from date of recruitment to date of death from any cause or the last date that has news of the patient). Measurement time: up to 2 years of follow-up after 1 dose of the monoclonal. Objective clinical response (MacDonals classification: complete response (RC), partial response (PR) stable disease (EE) and progression disease (PD)). Measurement time: the 12 weeks of treatment and every 3 months up to 2 years. Cognitive State (description according to the scale used). Measurement time: 6 months, 12 months and 24 months. EGFR Expression (immunohistochemistry evaluation in biopsy). Measurement time: at baseline and if surgery is needed again. Images markers (magnetic resonance imaging and magnetic resonance spectroscopy. Measurement time: at baseline and every 12 weeks until 2 years of follow-up.

Selection criterias

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

Gender:

Male/Female

Minimum age:

2 years

Maximum age:

19 years

Inclusion criteria:

1. Children and adolescents between 2 and 19 years of age of btoh gender (male and female) 2. Diagnoses by histology/pathology documented or by images if stem tumor. 3. Life expectancy of at least 4 weeks. 4. Karnofsky / Lansky ≥ 50%.

Exclusion criteria:

1. Participation in another trial. 2. Pregnant or breastfeeding. 3. Decompensated chronic disease. 4. Acute septic processes.

Type of population:

Children

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

Other design:

3 Schemes of treatment which include nimotuzumab as monotherapy or in combination with other therapies.

Phase:

N/A

Target sample size:

160

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:

Dr. Giselle

Last Name:

Saurez Martinez

Specialty:

Specialist in Integral General Medicine and Pharmacology

Affiliation:

CIMAB S.A

Postal Address:

Street 206. No. 1926. E/19 and 21. Atabey. Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-271 50 57 Ext. 111

Email :

giselle@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:

Giselle

Last Name:

Saurez Martinez

Specialty:

Specialist in General Medicine and Integral

Affiliation:

CIMAB S.A

Postal Address:

Street 206. No. 1926. E/19 and 21. Atabey. Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537 271 50 57 Ext.111

Email :

giselle@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:

RPCEC00000183

Date of Registration in Primary Registry:

14/08/2014

Record Verification Date:

2014/08/14

Next update date:

2015/08/14

Link to the spanish version:

Click here [3]