Nimotuzumab for the treatment of high grade of malignancy 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:

Nimotuzumab for the treatment of high grade of malignancy tumors. Study of safety and effectiveness.

Secondary indentifying numbers:

M9/CIMAB/AEC-03

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

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:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

06/11/2012

Reference number:

24.151.12.B

Principal investigator

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

First name:

Silvia Noema Salva.MD.Specialist in Neurosurgery

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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:

Pinar del Río,III Congress,Rosa M. Amador Glez.MD. Specialist in Oncology.Radiotherapy Villa Clara,Arnaldo Milián Castro,Jorge Abel Anoceto.MD.Specialist in Neurosurgery Holguín,Lucía Iñiguez,Aracelis Salomón Vila.MD.Specialist in Neurosurgery Stgo. de Cuba,Saturnino Lora, Rafael Domínguez Peña.MD,Specialist in Neurosurgery

Research ethics committees:

Hermanos Ameijeiras,September 3,2012 III Congress,October 22,2012 Lucía Iñiguez,October 31,2012 Saturnino Lora,November 14,2012 Arnaldo Milián Castro,November 20,2012

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/02/2013

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 glial tumors

Intervention(s):

Sudy group (Nimotuzumab). 200 mg of monoclonal antibody Nimotuzumab (bulb of 50mg/10 mL) by intravenous route (antecubital vein), diluted in 250 mL of saline solution 0.9% (290 mL total volume), in 30-minute infusion. The treatment consists of 2 phases: Phase induction weekly during 6 weeks + Radiotherapy, a time/day to 1.8 - 2 Gy, fractionated in 5 d/week, total of 60Gy, beginning the first day of the RT. Maintenance or consolidation phase: After the induction phase, once every 2 weeks, will be administered to impairment of functional capacity or not tolerated toxicity or end of the study (2 years).

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):

Incidence of serious adverse events or deaths with causal relationship with the product under study(number of serious adverse events or deaths).Measuring time:24 months

Key secondary outcomes:

Occurrence of any adverse event(AE)(yes/no).Measuring time:24 months Description of the AE (name of each event occurring).Measuring time:24 months Duration of the adverse event(minutes,hours,days).Measuring time:24 months Intensity of the AE(Grade 1:mild,Grade 2:moderate,Grade 3:severe,Grade 4:life-threatening or disabling AE,Grade 5: death).Measuring time:24 months Severity of the AE(serious, not serious).Measuring time:24 months Result of the AE(death,risk of death,hospitalization/prolongation of hospitalization,persistent or significant, disability congenital anomaly / birth defect.Measuring time:24 months Causality relationship(1.Very likely/Safe/Definitive,2.Likely,3.Possible,4.Unlikely,5.Not related,6.Unknown).Measuring time:24 months Overall survival time(days).Measuring time:from the date of inclusion of each patient up to the date of death or the last date that has news of the patient. Progression-free survival(days).Measuring time:from the date of inclusion of each patient until the date of determination of the progression, death or last date that has news of the patient. Clinic response(complete response (CR),partial response (PR), stable disease (SD)and disease progression (DP).Measuring time:the 12 weeks of treatment and every 3 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:

N/A (No limit)

Inclusion criteria:

1.Patients with tumors glial with high-grade malignancy confirmed by pathology techniques, at the time of the inclusion in the trial, are candidates for treatment oncoespecifico or patients with the same diagnosis found in relapse, confirmed by pathology or Imaging. 2.Patients with age = 18 years of either sex. 3.General State of health according to Karnofsky index = 50%. 4.Laboratory parameters within the limits normal defined as: Hematopoietic: Hemoglobin = 9 g/l, total leukocytes = 3 x 109 cells/L, platelets = 100 x 109/l. Hepaticos: TGP/TGO and alkaline phosphatase up to 2.5 times upper limit of normal. 5.Patients expressed by voluntariness to participate in the study and informed consent signature. 6.Female patients in childbearing age who possess a negative pregnancy test and/or use effective contraception(intrauterine devices,hormonal contraceptives, tubal ligation or barrier method)in the case of male (vasectomy, condom use) prior to its inclusion and/or during your participation in the study.

Exclusion criteria:

1.Pregnancy or breastfeeding. 2.A second concomitant tumour patients. 3.Presence of decompensated associated chronic disease (heart disease, diabetes, hypertension). 4.A history of hypersensitivity to recombinant proteins. 5.Acute and severe allergic states. 6.Febrile states. 7.Acute septic processes. 8.Treatment with nimotuzumab 6 months prior to the inclusion.

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:

4

Target sample size:

Inclusion of two 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:

Patricia

Last Name:

Piedra Sierra

Affiliation:

Center of Molecular Immunology, CIMAB S.A

Postal Address:

206 Street No.1926 e/19 y 21,Atabey,Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

537-2715057 Ext.111

Email :

patrip@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:

Patricia

Last Name:

Piedra Sierra

Affiliation:

Center of Molecular Immunology, CIMAB SA.

Postal Address:

206 Street No.1926 e/19 y 21,Atabey,Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

537-2715057 Ext.111

Email :

patrip@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:

RPCEC00000146

Date of Registration in Primary Registry:

2013-02-01

Record Verification Date:

2013-01-21 19:00

Link to the spanish version:

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Nimotuzumab for the treatment of high grade of malignancy tumors

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