MAGINC Study

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:

Exploratory, adaptive, randomized, double blind, multicentre study, of HeberPAG® intralesional application in recurrent or progressive Malignant Gliomas, degree III and IV.

Secondary indentifying numbers:

IG/AGI/NC/0801

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), in Havana. Ministry of Public Health, Cuba.

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 :

02/02/2010

Reference number:

05-029-09-B

Principal investigator

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

First name:

Silvia Salva Camaño MD

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 [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:

Camagüey, "Manuel Ascunce Domenech" Clinical - Surgical Hospital, Rigoberto Piñones Montero MD. Granma, "Carlos M. de Céspedes" Clinical - Surgical Hospital, Maria Luisa Álvarez Jeréz MD. Holguín, "Lucía Iñiguez" Clinical - Surgical Hospital, Julio César Selva Infante MD.

Research ethics committees:

Clinical - Surgical Hospital "Hermanos Ameijeiras", September 23, 2009. "Manuel Ascunce Domenech" Clinical - Surgical Hospital, April 12, 2010. "Carlos M. de Céspedes" Clinical - Surgical Hospital, May 11, 2010. "Lucía Iñiguez" Clinical - Surgical Hospital, September 15, 2010.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

19/04/2010

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 Glioma

Intervention(s):

HeberPAG be administered 3 times per week (1st month), 2 times per week (weeks 5-16) and 1 time per week (weeks 17-26), by intralesional through a reservoir intracranial and randomly according to dose group: a) 0,875 million IU b) 1.75 million IU c) 3.5 million IU d) 7 million IU

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):

Clinical adverse events (type, duration, intensity, outcome and causality) through questioning and physical examination. Measuring time: 30 minutes, 1 hour and 12 hours after 1st, 2nd and 3rd administration of the product, and every four weeks post-treatment to progression or death of the patient. Laboratory tests (complete blood count, platelet count, coagulation least ASAT, ALAT, FAL, LDH, creatinine, glucose, total protein, albumin, CPK, electrolytes). Measuring time: 72 hours weekly (weeks 1-4) and monthly (up to the end of treatment).

Key secondary outcomes:

Progression-free survival. Measuring time: 6 and 12 months. Survival. Measuring time: 6 and 12 months, and even fatal. Anti-tumor response (according to RECIST criteria)). Measuring time: 6 months and annually after start of treatment to progression or death of the patient. Clinical response (according to MacDonald criteria). Measuring time: 6 months and annually thereafter until progression or death of the patient Quality of life, functional ability, motor function/sensory and neuropsychological assessment. Measuring time: 1st month and every 2 months after starting treatment, until progression or death of the patient. Steroids use (Yes/No). Measuring time: at the end of the study. Protein expression in tumor tissue. Measuring time: at the beginning.

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. Age = 18 years and both genders. 2. Patients with glioma degree III and IV confirmed previously by histological techniques. 3. Recurrent or progressive illness diagnosed by imaging to 14 prior days to the inclusion and after the patient has received the conventional treatment (Surgery + RT). 4. Only supratentorial tumor, in a single hemisphere that in their bordering locating they affect no more than 2 cerebral lobes, without invasion of basal ganglias, callused body or ventricular.system 5. Absence of clinical signs and/or imaging of cerebral herniation if the endocranianal hypertension exists at moment of the inclusion.. 6. Karnofsky performance state = 60%. 7. Expectation of life = 6 months. 8. Parameters of clinical laboratory (to 7 prior days to the inclusion): - Hb = 10 g/L; total leukocytes = 4 x 109 cells/L; platelets = 150 x 109/L. - Normal creatine phosphokinase (CPK). - Liver operation inside normal limits and/or without antecedents of some liver affection shown by ASAT, ALAT or FAL, - Normal renal function: serum creatinine = 132 mmol/L. 9. Patients in fertile age should utilize an efficient contraceptive method for three months after the last dose of treatment. 10. Express voluntariness written of the patient.

Exclusion criteria:

1. Pregnancy or lactation. 2. Hypersensitivity to the HeberPAG® or other preparations utilized in the study. 3. Intractable convulsions medically. 4. Signs of medular affectation. 5. Serious inconveniences of the coagulation. 6. Serious arterial hypertension or ischemic heart disease and/or diabetes mellitus uncompensated verified by the clinical exam. 7. Patients dealt with immunotherapy in the last three months or that are receiving another type of specific oncological treatment in the last 15 days. 8. Patient that are participating or they have participated recently (1 month) in another study. 9. Sepsis of the Central Nervous System or of the place where should be placed the reservoir. 10. Severe psychiatric inconvenience or another limitation that impede the patient to give its consent or complicate its evaluation.

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:

Double Blind

Control group:

Uncontrolled

Study design:

Parallel

Phase:

1-2

Target sample size:

120

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:

MSc. Idrián

Last Name:

García García

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

idrian.garcia@cigb.edu.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:

Dr. Iraldo

Middle Name:

Jesús

Last Name:

Bello Rivero

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

iraldo.bello@cigb.edu.cu [3]

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:

RPCEC00000120

Date of Registration in Primary Registry:

2011-07-12

Record Verification Date:

2011-06-30 20:00

Link to the spanish version:

Click here [4]