Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Subject must be able to consent for self. Subject must have either:

1. a brain metastasis or

2. 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.

Exclusion Criteria:

• Medical contraindication for magnetic resonance imaging (MRI)testing.