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Antineoplastons vs Temozolomide in Recurrent Optic Pathway Glioma
NCT01260103Phase 3
Key facts
- Status
- Withdrawn
- Start
- Dec 2011
- Primary completion
- Dec 2016
- Sponsor
- Burzynski Research Institute
- Modality
- Peptides, Small Molecules
- Conditions
- optic pathway glioma (OPG)
01
Overview
Phase 3, randomised, open-label trial of antineoplaston A10 and antineoplaston AS2-1 in optic pathway glioma (OPG), sponsored by Burzynski Research Institute. Primary endpoint: Progression Free Survival at 5 years. Planned start Dec 2011; status: withdrawn.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Children aged 6 months to <18 years with recurrent/progressive optic pathway glioma after carboplatin or cisplatin therapy.
04
Endpoints
Primary
Progression Free Survival
Secondary
Safety Analysis
Overall Survival
Disease Stabilization Rate
Response Rates (CR, PR, SD, PD)
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