drugset / Trial / NCT01833273

Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA

NCT01833273 ↗

NaSingle-groupOpen-labelTreatment

Summary

In order to test the investigators hypothesis that 8 teaspoons of POLYMVA is safe in a population of patients with grade IV brain astrocytoma (glioblastoma multiforme), the investigators will conduct an open-label, prospective, un-blinded study. The investigators expect that at least 70% of subjects will tolerate the supplement and complete the trial. The investigators expect no Serious Adverse Event to occur during this trial which is attributable to study compound. During this study, the investigators will also collect other qualitative data to be utilized for future double-blinded studies which will be aimed at determining whether grade IV astrocytoma patients who receive PolyMVA achieve a better quality of life during their chemo-therapeutic regimens versus grade IV astrocytoma patients who do not receive PolyMVA.

Timeline

Start
2010-07
Primary completion
2013-10
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject PolyMVA Other / unclassified 8 unknown Oral

Indications