Glioblastoma MultiformePhase 2NCT05120284
Trial of Dichloroacetate (DCA) in Glioblastoma Multiforme (GBM)
A Phase 2 study testing Dichloroacetate (DCA) and Genotype in people with Glioblastoma Multiforme, run by University of Florida at 2 sites in United States.
Trial summary
Conduct a multicenter, open label Phase IIA trial of oral DCA in 40 surgical patients with recurrent GBM who have clinically indicated debulking surgery planned. No patients will be recruited at UF. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Dichloroacetate (DCA) and Genotype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2022to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study subjects will be male and female adults, aged 18 through 80 years, previously diagnosed with a GBM who have experienced tumor recurrence as determined by neuroimaging and some degree of symptomatology (e.g., headache, mental status change, seizure) and have clinically indicated tumor debulking surgery planned.
- All subjects will have completed initial, standard- therapy with surgical debulking, followed by radiation and temozolomide (TMZ) and will, therefore, be considered treatment failures. Patients with truly unmethylated GBM do not require prior treatment with temozolomide (TMZ).
- Patients will be recruited and studied at Johns Hopkins University, Johns Hopkins affiliated Sibley Memorial Hospital, and Wake Forest University. The DCA liquid formulation is on file with the FDA, is identical to that administered in our Phase I trial of brain tumor patients and can be given by mouth or feeding tube. Patients may retain whatever medications they are receiving for other conditions (e.g., hypertension, seizures), except patients requiring insulin or sulfonylurea therapy (see below).
- The probability of adverse drug-drug interactions is extremely low, for the following reasons. First, DCA is the only pharmaceutical in clinical use that is metabolized by GSTZ1. Second, DCA is not known to be metabolized by any other drug metabolizing enzyme system, thus precluding competition with other agents for biotransformation. Third, the results of both open label and randomized controlled trials of orally or parenterally administered DCA in the treatment of children and/or adults have never shown evidence of adverse drug-drug interactions (34). Thus, from decades of clinical investigations of use of DCA in various acutely or chronically ill populations, there is nothing to suggest adverse drug-drug interactions should be anticipated in this trial.
- Patients who are diabetic must have a screening hemoglobin A1c (Hgb A1c) level of at least 6.0.
Who cannot join
- Patients considered pre-terminal (life expectancy ≤ 2 months)
- Those who are pregnant will be excluded.
- DCA inhibits gluconeogenesis and lowers blood glucose levels in patients with type 2 diabetes. Therefore, in subjects who are receiving either insulin or a sulfonylurea, coadministration of DCA could lead to symptomatic hypoglycemia and those patients will be excluded from the trial.
- DCA is dialyzable and its clearance diminishes in patients with end stage renal failure (GFR ≤ 30 ml/min); such patients will be excluded from participating.
- DCA is metabolized by hepatic GSTZ1, so patients with severe liver insufficiency (total bilirubin > 2.0 mg/dl or ALT or AST > 3 x ULN) will be excluded.
- Patients with Hgb A1c level less than 6.0 at screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Wake Forest University
Winston-Salem, North Carolina, 27587
About this study
Conduct a multicenter, open label Phase IIA trial of oral DCA in 40 surgical patients with recurrent GBM who have clinically indicated debulking surgery planned. No patients will be recruited at UF. Patients will be genotyped to establish safe dosing regimens and will be randomized to receive DCA (N=20) or no DCA (N=20) for one week prior to surgery. Deidentified blood and tumor tissue obtained at surgery will be assessed at UF for biochemical markers of DCA dynamics.
Read the detailed description
Evaluate effects of dichloroacetate (DCA) on tumor PDC phosphorylation.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Dichloroacetate (DCA), Genotype
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dichloroacetate (DCA)Drug
Also called Sodium Dichloroacetate
Study medication DCA is a liquid formulation mixed with an artificial sweetener containing aspartame and strawberry extract (50mg/mL)
Participants will be genotyped to determine GSTZ1 (glutathione S-transferase Zeta-1) haplotype status, which will stratify this group into 1 of 2 dose regimens:
EGT carriers will receive 12-14 mg/kg/12hr DCA. EGT non-carriers will receive 6-7 mg/kg/12 hr.
GenotypeGenetic
Participants will be genotyped to determine GSTZ1 haplotype status.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Surgical Dichloroacetate (DCA) | Active comparator | Study medication begins in subjects randomized to preoperative DCA. All subjects will be given the 12.5 mg/kg/12 hour DCA for pre-surgical dosing. Post-surgery the GSTZ1 haplotype will be utilized to dose all patients. Receives: Drug: Dichloroacetate (DCA); Genetic: Genotype |
| No Pre-Surgical Dichloroacetate (DCA) | Active comparator | Subject randomized to start DCA after surgery will do so 12-24 hours postoperatively, depending on their ability to safely receive medication. Receives: Drug: Dichloroacetate (DCA); Genetic: Genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of phosphorylated PDC protein expressed in surgical tissue
The efficacy of dichloroacetate will be determined by the level of phosphorylated PDC protein expressed in surgical tissue.
Measured: Within 4 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jul 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- subsequent ordered and alternating patients
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stacpoole, PhD, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120284
- Sponsor's protocol ID
- IRB202101509
- Other IDs
- FD-R-007271-01, PRO00034631
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunbar 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.
PubMed 24297161Patel MS, Korotchkina LG, Sidhu S. Interaction of E1 and E3 components with the core proteins of the human pyruvate dehydrogenase complex. J Mol Catal B Enzym. 2009 Nov 1;61(1-2):2-6. doi: 10.1016/j.molcatb.2009.05.001.
PubMed 20160912Stacpoole PW. The pyruvate dehydrogenase complex as a therapeutic target for age-related diseases. Aging Cell. 2012 Jun;11(3):371-7. doi: 10.1111/j.1474-9726.2012.00805.x. Epub 2012 Apr 4.
PubMed 22321732Kankotia S, Stacpoole PW. Dichloroacetate and cancer: new home for an orphan drug? Biochim Biophys Acta. 2014 Dec;1846(2):617-29. doi: 10.1016/j.bbcan.2014.08.005. Epub 2014 Aug 23.
PubMed 25157892DeBerardinis RJ, Chandel NS. Fundamentals of cancer metabolism. Sci Adv. 2016 May 27;2(5):e1600200. doi: 10.1126/sciadv.1600200. eCollection 2016 May.
PubMed 27386546Semenza GL. Oxygen sensing, homeostasis, and disease. N Engl J Med. 2011 Aug 11;365(6):537-47. doi: 10.1056/NEJMra1011165. No abstract available.
PubMed 21830968Brizel DM, Schroeder T, Scher RL, Walenta S, Clough RW, Dewhirst MW, Mueller-Klieser W. Elevated tumor lactate concentrations predict for an increased risk of metastases in head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Oct 1;51(2):349-53. doi: 10.1016/s0360-3016(01)01630-3.
PubMed 11567808Walenta S, Wetterling M, Lehrke M, Schwickert G, Sundfor K, Rofstad EK, Mueller-Klieser W. High lactate levels predict likelihood of metastases, tumor recurrence, and restricted patient survival in human cervical cancers. Cancer Res. 2000 Feb 15;60(4):916-21.
PubMed 10706105Walenta S, Schroeder T, Mueller-Klieser W. Lactate in solid malignant tumors: potential basis of a metabolic classification in clinical oncology. Curr Med Chem. 2004 Aug;11(16):2195-204. doi: 10.2174/0929867043364711.
PubMed 15279558Park I, Larson PE, Zierhut ML, Hu S, Bok R, Ozawa T, Kurhanewicz J, Vigneron DB, Vandenberg SR, James CD, Nelson SJ. Hyperpolarized 13C magnetic resonance metabolic imaging: application to brain tumors. Neuro Oncol. 2010 Feb;12(2):133-44. doi: 10.1093/neuonc/nop043. Epub 2010 Jan 25.
PubMed 20150380Saraswathy S, Crawford FW, Lamborn KR, Pirzkall A, Chang S, Cha S, Nelson SJ. Evaluation of MR markers that predict survival in patients with newly diagnosed GBM prior to adjuvant therapy. J Neurooncol. 2009 Jan;91(1):69-81. doi: 10.1007/s11060-008-9685-3. Epub 2008 Sep 23.
PubMed 18810326Kahlon AS, Alexander M, Kahlon A, Wright J. Lactate levels with glioblastoma multiforme. Proc (Bayl Univ Med Cent). 2016 Jul;29(3):313-4. doi: 10.1080/08998280.2016.11929449.
PubMed 27365883Haas R, Cucchi D, Smith J, Pucino V, Macdougall CE, Mauro C. Intermediates of Metabolism: From Bystanders to Signalling Molecules. Trends Biochem Sci. 2016 May;41(5):460-471. doi: 10.1016/j.tibs.2016.02.003. Epub 2016 Feb 28.
PubMed 26935843Ippolito L, Morandi A, Giannoni E, Chiarugi P. Lactate: A Metabolic Driver in the Tumour Landscape. Trends Biochem Sci. 2019 Feb;44(2):153-166. doi: 10.1016/j.tibs.2018.10.011. Epub 2018 Nov 22.
PubMed 30473428Feron O. Pyruvate into lactate and back: from the Warburg effect to symbiotic energy fuel exchange in cancer cells. Radiother Oncol. 2009 Sep;92(3):329-33. doi: 10.1016/j.radonc.2009.06.025. Epub 2009 Jul 13.
PubMed 19604589
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Dichloroacetate (DCA) in Glioblastoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT05120284
- Acronym / sponsor ID
- IRB202101509
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conduct a multicenter, open label Phase IIA trial of oral DCA in 40 surgical patients with recurrent GBM who have clinically indicated debulking surgery planned. No patients will be recruited at UF. Patients will be genotyped to establish safe dosing regimens and will be randomized to receive DCA (N=20) or no DCA (N=20) for one week prior to surgery. Deidentified blood and tumor tissue obtained at surgery will be assessed at UF for biochemical markers of DCA dynamics.
Detailed description
Evaluate effects of dichloroacetate (DCA) on tumor PDC phosphorylation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- subsequent ordered and alternating patients
| Arm | Type | Receives |
|---|---|---|
| Pre-Surgical Dichloroacetate (DCA) | Active comparator | Drug: Dichloroacetate (DCA), Genetic: GenotypeStudy medication begins in subjects randomized to preoperative DCA. All subjects will be given the 12.5 mg/kg/12 hour DCA for pre-surgical dosing. Post-surgery the GSTZ1 haplotype will be utilized to dose all patients. |
| No Pre-Surgical Dichloroacetate (DCA) | Active comparator | Drug: Dichloroacetate (DCA), Genetic: GenotypeSubject randomized to start DCA after surgery will do so 12-24 hours postoperatively, depending on their ability to safely receive medication. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Study subjects will be male and female adults, aged 18 through 80 years, previously diagnosed with a GBM who have experienced tumor recurrence as determined by neuroimaging and some degree of symptomatology (e.g., headache, mental status change, seizure) and have clinically indicated tumor debulking surgery planned.
- All subjects will have completed initial, standard- therapy with surgical debulking, followed by radiation and temozolomide (TMZ) and will, therefore, be considered treatment failures. Patients with truly unmethylated GBM do not require prior treatment with temozolomide (TMZ).
- Patients will be recruited and studied at Johns Hopkins University, Johns Hopkins affiliated Sibley Memorial Hospital, and Wake Forest University. The DCA liquid formulation is on file with the FDA, is identical to that administered in our Phase I trial of brain tumor patients and can be given by mouth or feeding tube. Patients may retain whatever medications they are receiving for other conditions (e.g., hypertension, seizures), except patients requiring insulin or sulfonylurea therapy (see below).
- The probability of adverse drug-drug interactions is extremely low, for the following reasons. First, DCA is the only pharmaceutical in clinical use that is metabolized by GSTZ1. Second, DCA is not known to be metabolized by any other drug metabolizing enzyme system, thus precluding competition with other agents for biotransformation. Third, the results of both open label and randomized controlled trials of orally or parenterally administered DCA in the treatment of children and/or adults have never shown evidence of adverse drug-drug interactions (34). Thus, from decades of clinical investigations of use of DCA in various acutely or chronically ill populations, there is nothing to suggest adverse drug-drug interactions should be anticipated in this trial.
- Patients who are diabetic must have a screening hemoglobin A1c (Hgb A1c) level of at least 6.0.
Key exclusion criteria (6 listed)
- Patients considered pre-terminal (life expectancy ≤ 2 months)
- Those who are pregnant will be excluded.
- DCA inhibits gluconeogenesis and lowers blood glucose levels in patients with type 2 diabetes. Therefore, in subjects who are receiving either insulin or a sulfonylurea, coadministration of DCA could lead to symptomatic hypoglycemia and those patients will be excluded from the trial.
- DCA is dialyzable and its clearance diminishes in patients with end stage renal failure (GFR ≤ 30 ml/min); such patients will be excluded from participating.
- DCA is metabolized by hepatic GSTZ1, so patients with severe liver insufficiency (total bilirubin > 2.0 mg/dl or ALT or AST > 3 x ULN) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dichloroacetate (DCA)Also: Sodium DichloroacetateStudy medication DCA is a liquid formulation mixed with an artificial sweetener containing aspartame and strawberry extract (50mg/mL) Participants will be genotyped to determine GSTZ1 (glutathione S-transferase Zeta-1) haplotype status, which will stratify this group into 1 of 2 dose regimens: EGT carriers will receive 12-14 mg/kg/12hr DCA. EGT non-carriers will receive 6-7 mg/kg/12 hr. | Drug | No Pre-Surgical Dichloroacetate (DCA), Pre-Surgical Dichloroacetate (DCA) |
| GenotypeParticipants will be genotyped to determine GSTZ1 haplotype status. | Genetic | No Pre-Surgical Dichloroacetate (DCA), Pre-Surgical Dichloroacetate (DCA) |
Primary outcome
Level of phosphorylated PDC protein expressed in surgical tissue
Time frame: Within 4 weeks post surgery
The efficacy of dichloroacetate will be determined by the level of phosphorylated PDC protein expressed in surgical tissue.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 24297161Dunbar 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.
- Background: PubMed 20160912Patel MS, Korotchkina LG, Sidhu S. Interaction of E1 and E3 components with the core proteins of the human pyruvate dehydrogenase complex. J Mol Catal B Enzym. 2009 Nov 1;61(1-2):2-6. doi: 10.1016/j.molcatb.2009.05.001.
- Background: PubMed 22321732Stacpoole PW. The pyruvate dehydrogenase complex as a therapeutic target for age-related diseases. Aging Cell. 2012 Jun;11(3):371-7. doi: 10.1111/j.1474-9726.2012.00805.x. Epub 2012 Apr 4.
- Background: PubMed 25157892Kankotia S, Stacpoole PW. Dichloroacetate and cancer: new home for an orphan drug? Biochim Biophys Acta. 2014 Dec;1846(2):617-29. doi: 10.1016/j.bbcan.2014.08.005. Epub 2014 Aug 23.
- Background: PubMed 27386546DeBerardinis RJ, Chandel NS. Fundamentals of cancer metabolism. Sci Adv. 2016 May 27;2(5):e1600200. doi: 10.1126/sciadv.1600200. eCollection 2016 May.
- Background: PubMed 21830968Semenza GL. Oxygen sensing, homeostasis, and disease. N Engl J Med. 2011 Aug 11;365(6):537-47. doi: 10.1056/NEJMra1011165. No abstract available.
- Background: PubMed 11567808Brizel DM, Schroeder T, Scher RL, Walenta S, Clough RW, Dewhirst MW, Mueller-Klieser W. Elevated tumor lactate concentrations predict for an increased risk of metastases in head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Oct 1;51(2):349-53. doi: 10.1016/s0360-3016(01)01630-3.
- Background: PubMed 10706105Walenta S, Wetterling M, Lehrke M, Schwickert G, Sundfor K, Rofstad EK, Mueller-Klieser W. High lactate levels predict likelihood of metastases, tumor recurrence, and restricted patient survival in human cervical cancers. Cancer Res. 2000 Feb 15;60(4):916-21.
- Background: PubMed 15279558Walenta S, Schroeder T, Mueller-Klieser W. Lactate in solid malignant tumors: potential basis of a metabolic classification in clinical oncology. Curr Med Chem. 2004 Aug;11(16):2195-204. doi: 10.2174/0929867043364711.
- Background: PubMed 20150380Park I, Larson PE, Zierhut ML, Hu S, Bok R, Ozawa T, Kurhanewicz J, Vigneron DB, Vandenberg SR, James CD, Nelson SJ. Hyperpolarized 13C magnetic resonance metabolic imaging: application to brain tumors. Neuro Oncol. 2010 Feb;12(2):133-44. doi: 10.1093/neuonc/nop043. Epub 2010 Jan 25.
- Background: PubMed 18810326Saraswathy S, Crawford FW, Lamborn KR, Pirzkall A, Chang S, Cha S, Nelson SJ. Evaluation of MR markers that predict survival in patients with newly diagnosed GBM prior to adjuvant therapy. J Neurooncol. 2009 Jan;91(1):69-81. doi: 10.1007/s11060-008-9685-3. Epub 2008 Sep 23.
- Background: PubMed 27365883Kahlon AS, Alexander M, Kahlon A, Wright J. Lactate levels with glioblastoma multiforme. Proc (Bayl Univ Med Cent). 2016 Jul;29(3):313-4. doi: 10.1080/08998280.2016.11929449.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stacpoole, PhD, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dichloroacetate (DCA) and Genotype in people with Glioblastoma Multiforme, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of phosphorylated PDC protein expressed in surgical tissue (time frame: Within 4 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120284, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.