A study to assess safety and effectiveness of oral medicine of valproate in advanced brain tumors
Phase 1
- Conditions
- Health Condition 1: null- Recurrent/ Progressive brain Tumors
- Registration Number
- CTRI/2012/12/003180
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 30
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
1)Pregnancy or lactating
2)Uncontrolled infection
3)Expected poor compliance
4)Organ dysfunction or metabolic disorder
5)Concurrent radiotherapy, biologic therapy or immunotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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/m
- Secondary Outcome Measures
Name Time Method To assess the progression free survival and overall survivalTimepoint: 6 months to 1 year