Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors
Completed · Phase 1
Conditions studied: Brain Tumor, Glioblastoma
In brief
The purpose of this study is to evaluate the safety and tolerability of oral Dichloroacetate (DCA) in the treatment of recurrent malignant brain tumors (RMBTs). RMBTs are defined as either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2) malignant tumors originating elsewhere in the body that have spread to the brain at least once. Otherwise, there are no limitations to the number of prior recurrences. There are no limitations to the number or types of prior therapies.
Key facts
- Study ID
- NCT01111097
- Run by
- University of Florida
- People needed
- 15
- Starts
- 2010-04-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2015-09-22
Who can join
Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject must be able to consent for self. Subject must have either:
- a brain metastasis or
- a WHO III-IV glioma that has recurred at least once. Females of child bearing age must have (-) pregnancy test.
- Females of child bearing age must use birth control while in study.
- Adequate organ function as determined by laboratory testing.
- Absence of peripheral neuropathy of moderate or greater severity (physician determined).
- Greater than 4 weeks time from previous anti-neoplastic (anti-cancer) therapy.
- Subject must have a Karnofsky Performance Status (KPS) of greater than or equal to 60.
- Subject must have an ECOG performance status of less than or equal to 2.
- There are no limitations to the number of prior recurrences.
- There are no limitations to the number or types of prior therapies.
You may not qualify if…
- Medical contraindication for magnetic resonance imaging (MRI)testing.
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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