Health Condition 1: null- Recurrent/ Progressive brain Tumors
Conditions
Interventions
Intervention1: Valproate/valproic Acid: Valproate is available as 200mg, 300mg and 500mg controlled release tablets which will be used in this study. The total dose will be rounded off to the nearest
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Age 5-65yrs 2) KPS/Lansky 50 3) Adequate Organ function ( CBC,RFT and LFT) 4) Life expectancy of around 6 Months 5) At least 4 weeks from last chemo therapy or radio therapy 6)No other concurrent anti epileptic agents except valproate ( patients receiving valproate before enrolling in study should have total through VA concentration 100�g/mL within past 2 weeks) 7) Signed study specific consent form from patients if (adults) and guardians or legally accepted Representatives (If children) Assent from children
Exclusion criteria
Exclusion criteria: 1) Pregnancy or lactating 2) Uncontrolled infection 3) Expected poor compliance 4) Organ dysfunction or metabolic disorder 5) Concurrent radiotherapy, biologic therapy or immunotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the toxicity of oral valproic acid ( VA) administered at doses required to maintain serum trough VA concentrations of 100 to 150µg/mLTimepoint: Monitoring for toxicity will be done weekly during dose escalation phase and 4 weekly after achieving serum trough concentration of 100-150µg/mL | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the progression free survival and overall survivalTimepoint: 6 months to 1 year | — |
Countries
India
Contacts
Public ContactDr Tejpal Gupta
Tata Memorial Centre Tata Memorial Hospital and ACTREC
Outcome results
None listed