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Metabolic Modulator

Dichloroacetate for Glioblastoma (DCA Trial)

Phase 2
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have the following organ and marrow function: (1) Absolute neutrophil count >1,500/ µL (2) Platelets ≥100,000/ µL (3) Hemoglobin ≥ 9 g/dL (4) Total bilirubin ≤ 2mg/dl (5) AST (SGOT)/ALT (SGPT) ≤3 × institutional upper limit of normal (6) GFR > 30ml/min
Patients must have histologically confirmed WHO grade IV glioma that is progressive or recurrent following at least one prior TMZ plus radiation therapy regimen
Must not have
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
Patients who require insulin or sulfonylurea therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial tests DCA, a medicine that helps fix cell energy problems, in patients with recurring brain tumors who didn't respond to standard treatments. DCA works by restarting normal cell energy processes to kill cancer cells. DCA has shown activity against several human cancers and has been tested in early research for its potential to treat brain tumors.

Who is the study for?
Adults aged 18-80 with WHO grade IV glioma that's worsening or returning after treatment, able to care for themselves mostly, and not on insulin/sulfonylurea therapy. They must have adequate organ function, be off certain treatments for specific periods, use effective contraception if applicable, and be scheduled for tumor removal surgery.
What is being tested?
The trial is testing Dichloroacetate (DCA), a new type of drug that targets cancer cell metabolism in the brain. It aims to show that DCA can reduce a particular protein in tumors when given before surgery compared to those who don't receive it beforehand.
What are the potential side effects?
While the side effects of DCA are not detailed here, similar drugs may cause issues like nerve damage (neuropathy), fatigue, changes in liver function tests, and possibly affect blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor has returned or worsened after treatment with TMZ and radiation.
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I have recurring brain cancer with symptoms and surgery planned to remove part of the tumor.
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I have waited the required time after my last cancer treatment before joining this trial.
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I am between 18 and 80 years old.
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I completed most of my planned radiation and chemotherapy for my condition.
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I can take care of myself with some help from others.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that could interfere with the study.
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I need insulin or sulfonylurea for my diabetes.
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I am not pregnant or breastfeeding if I am to be treated with DCA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Level of phosphorylated PDC protein expression in tumor tissue

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 - NO Pre-surgical dosingExperimental Treatment1 Intervention
Following recovery from surgical resection*, all patients will receive DCA at the determined individual dosing dose "fast" vs "slow". GSTZ1 haplotype analysis, into "fast" (i.e., EGT carriers; 12.5 mg/kg DCA every 12 hours ± 2hrs) or "slow" (i.e., EGT noncarriers; 6.25 mg/kg DCA every 12 hours ± 2hrs) drug metabolizers Post-surgery (upon recovery, within 2-4 weeks, DCA will be administered twice daily continuously for each 60 day cycle. Each dose should be taken 12 hours apart (±2 hours), at approximately the same times each day.
Group II: Arm 1 - Pre-surgical dosingExperimental Treatment1 Intervention
Dichloroacetate (DCA) will be given orally. Dosing will be 12.5 mg/kg/dose every 12 hours. DCA will be administered twice daily for 7 days prior to scheduled surgery to remove tumor. A final pre-surgical dose should be taken the morning the day before surgery, approximately 12 hours before the surgical procedure begins, i.e. skip evening dose. Following recovery from surgical resection*, all patients will receive DCA at the determined stratification dose "fast" vs "slow". GSTZ1 haplotype analysis, into "fast" (i.e., EGT carriers; 12.5 mg/kg DCA every 12 hours ± 2hrs) or "slow" (i.e., EGT noncarriers; 6.25 mg/kg DCA every 12 hours ± 2hrs) drug metabolizers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dichloroacetic acid
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Glioblastoma often target the unique metabolic pathways of cancer cells. Dichloroacetate (DCA), for example, inhibits pyruvate dehydrogenase kinase (PDK), which reactivates the pyruvate dehydrogenase complex (PDC). This shifts the cancer cell metabolism from glycolysis to glucose oxidation, increasing mitochondrial activity and inducing selective apoptosis of tumor cells. This approach is significant for Glioblastoma patients as it specifically targets the altered metabolic processes in cancer cells, potentially reducing tumor growth and improving survival rates.

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED
179 Previous Clinical Trials
1,543,591 Total Patients Enrolled
8 Trials studying Glioblastoma
355 Patients Enrolled for Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
568 Previous Clinical Trials
33,382 Total Patients Enrolled
34 Trials studying Glioblastoma
1,127 Patients Enrolled for Glioblastoma
Stuart Grossman, MDStudy DirectorJohns Hopkins/ABTCv2
4 Previous Clinical Trials
14 Total Patients Enrolled
3 Trials studying Glioblastoma
8 Patients Enrolled for Glioblastoma

Media Library

Dichloroacetate (Metabolic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05173623 — Phase 2
Glioblastoma Research Study Groups: Arm 1 - Pre-surgical dosing, Arm 2 - NO Pre-surgical dosing
Glioblastoma Clinical Trial 2023: Dichloroacetate Highlights & Side Effects. Trial Name: NCT05173623 — Phase 2
Dichloroacetate (Metabolic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05173623 — Phase 2
~18 spots leftby Dec 2026