MAGINC Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000120
• Date of registration: 12/07/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: MAGINC Study
• Scientific title: Exploratory, adaptive, randomized, double blind, multicentre study, of HeberPAG® intralesional application in recurrent or progressive Malignant Gliomas, degree III and IV.
• Date of first enrolment: 19/04/2010
• Target sample size: 120
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000120-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Uncontrolled Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: MSc. Idrián García García
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Iraldo Bello Rivero
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: N/A (No limit)
Gender: Both

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

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).

Secondary Outcome(s)

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.

Secondary ID(s)

IG/AGI/NC/0801

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Ministry of Public Health, Cuba