Health Condition 1: C729- Malignant neoplasm of central nervous system, unspecified
Conditions
Interventions
Intervention1: Memantine: A drug to prevent neuro cognitive decline.
Dose: 5 mg morning dose in week 1, 5 mg BD in week 2, 10 mg morning and 5 mg evening doses in week 3 and 10 mg BD from week 4 throu
Sponsors
Dr Niharika Bisht
Eligibility
Inclusion criteria
Inclusion criteria: Solid malignancies with upto 10 brain mets, largest 3 cm and cumulative volume upto 15cc. KPS 70 or above with RPA class 1or2 and stable extracranial disease. Normal kidney function and liver function. HMSE score greater than 18 and PGI BBD TDRS less than 38 at baseline. Patients on chemo/immunotherapy and life expectancy of at least 6 months.
Exclusion criteria
Exclusion criteria: Ages below 18 or above 70. More than 10 brain mets. ECOG 4 or KPS less than 70. Progressive disease at interim analysis at 3 months. Hepatic, renal impairment or thromboembolic disorders. History of neurocognitive disorders and on anti-psychotic treatment. Pregnant or nursing mothers. Memantine allergy, chronic use of benzodiazepines, alcohol or drug abuse. Previous history of SRS or EBRT to brain or surgical resection of brain mets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preservation of Neuro cognitive functionTimepoint: Assessments at Baseline, 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Time to cognitive failure Progression Free Survival Drug related side effectsTimepoint: 0,12,24 weeks | — |
Countries
India
Contacts
Public ContactDr Niharika Bisht
Army Hospital Research And Referral
Outcome results
None listed