Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: L-2,4-diamino-butyric
acid dihydrochloride (DAB) and Prazosin: a solution containing L-2,4-diamino-butyric acid dihydrochloride (DAB) at a concentration of 100 millimolar and Prazosin
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Histopathologically confirmed high grade glioma with MR evidence of neurosurgically significant recurrence or therapy - naive patient with MRI evidence of high grade glioma 2) Age range 18 to 75 3) Properly signed informed consent form 4) Karnofsky scale status 100
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Absence of informed consent 2) Age below 18 years or above 75 years 3) Extension of the lesion across midline to the contralateral hemisphere 4) Any other existing exclusion criteria for neurosurgical interventions of the Hospital 5) Karnofsky scale status less than 100
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Extension of time to recurrence according to RANO criteria for gliomas. 2) reduction of mortality and morbidity compared with the Neurosurgical Clinic s historical data.Timepoint: 1. Total treatment time: 3-5 days, total drug solution volume: 0,5-1,5 liter - depending on the patient s intracranial pressure and excised tumor s cavity size. 2. As per the standard protocol, chemotherapy and radiotherapy will be followed and status of tumor will be radiologically and clinically evaluated every 3 months. 3. 24 months with 18 months follow-up for each patient, consisting of clinical and MRI examination every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr N K Ventakaramana
Brains Super Speciality Hospital
Outcome results
None listed