Clinical trial · Interventional
Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors
Phase 1, Open-Label, Single-Arm, Clinical and Metabolomics Study of Dichloroacetate (DCA) in Adults With Recurrent Malignant Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dichloroacetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1
- description
- Subjects are given a dose of Dichloroacetate 4mg/kg twice a day for 30 days
- interventionNames
- Drug: Dichloroacetate
- type
- ACTIVE_COMPARATOR
- label
- Cohort 2
- description
- Subjects are given a dose of Dichloroacetate 12.5mg/kg twice a day for 30 days
- interventionNames
- Drug: Dichloroacetate
Primary outcomes (1)
- measure
- Determine the safety and tolerability of DCA in RMBTs.
- timeFrame
- Within 28 days of starting DCA +/- 3 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTDunbar EM, Coats BS, Shroads AL, Langaee T, Lew A, Forder JR, Shuster JJ, Wagner DA, Stacpoole PW. Phase 1 trial of dichloroacetate (DCA) in adults with recurrent malignant brain tumors. Invest New Drugs. 2014 Jun;32(3):452-64. doi: 10.1007/s10637-013-0047-4. Epub 2013 Dec 3. PMID 24297161