Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | April 2010 |
| End Date: | March 2014 |
Phase 1, Open-Label, Single-Arm, Clinical and Metabolomics Study of Dichloroacetate (DCA) in Adults With Recurrent Malignant Brain Tumors
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.
(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.
Malignant brain tumors are defined as any World Health Organization grade III-IV glioma and
any solid tumor metastasis (spread) to the brain. Recurrent malignant brain tumors (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. They share an increasing incidence, clinical and radiographic
characteristics, lack of effective therapies, tendency to recur, and poor outcome.
Importantly, recurrent malignant brain tumor's shared characteristics may be usefully
exploited by an emerging class of biologic agents called metabolic modulators of which
Dichloroacetate (DCA) is the drug in the class most thoroughly investigated clinically.
DCA's mechanism of action and tolerability have been extensively demonstrated in the
treatment of chronic metabolic disorders. Furthermore, the preciseness of DCA's mechanism of
action appears to target abnormal tumor cell metabolism.
any solid tumor metastasis (spread) to the brain. Recurrent malignant brain tumors (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. They share an increasing incidence, clinical and radiographic
characteristics, lack of effective therapies, tendency to recur, and poor outcome.
Importantly, recurrent malignant brain tumor's shared characteristics may be usefully
exploited by an emerging class of biologic agents called metabolic modulators of which
Dichloroacetate (DCA) is the drug in the class most thoroughly investigated clinically.
DCA's mechanism of action and tolerability have been extensively demonstrated in the
treatment of chronic metabolic disorders. Furthermore, the preciseness of DCA's mechanism of
action appears to target abnormal tumor cell metabolism.
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.
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