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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

DCA Trial Summary

This trial is testing whether a drug called dichloroacetate (DCA) can decrease a protein called phosphorylated PDC in cancer cells, compared to cancer cells from patients who are not treated with DCA.

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.Check my eligibility
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.See study design
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.

DCA Trial 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.

DCA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of phosphorylated PDC protein expression in tumor tissue

DCA 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

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,566 Total Patients Enrolled
6 Trials studying Glioblastoma
277 Patients Enrolled for Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,860 Total Patients Enrolled
31 Trials studying Glioblastoma
943 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial accept applicants of youthful age?

"The eligibility criteria for this trial necessitates that applicants must be between 18 and 80 years of age. Additionally, there are 36 trials open to those younger than 18 whereas 418 studies are available to individuals over 65."

Answered by AI

Is this an unprecedented clinical trial?

"Since 2020, the pharmaceutical compound dichloroacetate has been studied extensively. The first trial was funded by Medosome Biotec LLC in 2020 and involved 34 patients. Following these initial trials, Phase 3 approval for use of this drug was granted. At present, there are currently three active clinical studies involving Dichloroacetate being conducted at 10 sites across one nation."

Answered by AI

What is the projected enrollment size for this medical experiment?

"This clinical trial has ended its recruitment phase, with the initial posting taking place on October 10th 2022 and last update made in December 2021. If you are still looking for trials related to glioblastoma or Dichloroacetate, there are currently 442 studies and 3 studies respectively that accept new participants."

Answered by AI

What qualifications must potential participants meet in order to join this research trial?

"This medical trial is searching for 40 individuals between 18 and 80 years old with a diagnosis of glioblastoma. To be eligible, patients must have undergone neuroimaging to confirm their condition and present symptoms like headache or altered mental status. Additionally, candidates must have had tumor debulking surgery planned within the last 12 weeks, received at least 80% of Standard of Care Radiation Therapy (RT) and Temozolomide (TMZ), completed 4 weeks without any investigational agents not approved by The Food & Drug Administration (FDA), achieved Karnofsky Performance Status greater than 60%, waited 3 weeks since non-nit"

Answered by AI

Has Dichloroacetate been evaluated in any other experimental treatments?

"At present, 3 clinical trials for Dichloroacetate are in progress. One of these studies is currently undergoing phase 3 testing while the other two are located at Stanford, California with an additional 12 sites running tests across North America."

Answered by AI

Is recruitment for this trial open to participants?

"Unfortunately, this research endeavour has concluded its participant recruitment. Initially listed on 10th January 2022 and last updated 12th December 2021, it is no longer accepting enrollees. However, 442 studies for glioblastoma and 3 trials for Dichloroacetate are presently enlisting patients."

Answered by AI

To what degree is Dichloroacetate risky for those taking it?

"Dichloroacetate is rated as a 2 on our scale from 1 to 3, indicating that there are safety assurances stemming from Phase 2 trials, yet no data affirming efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial of Dichloroacetate in Glioblastoma
2022. "Trial of Dichloroacetate in Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05173623.
~22 spots leftby Dec 2026
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