RPCEC00000120RecruitingPhase 1
Exploratory, adaptive, randomized, double blind, multicentre study, of HeberPAG® intralesional application in recurrent or progressive Malignant Gliomas, degree III and IV.
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 sites120 target enrollmentStarted: July 12, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled trial. Masking: Double Blind. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
Eligibility Criteria
- Ages
- 18 years to /A (No limit) (—)
- Sex
- All
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.
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