← Back to Search

Metabolic Modulator

DCA for Glioblastoma

Phase 2
Recruiting
Led By Peter Stacpoole, PhD, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 weeks post surgery
Awards & highlights

Study Summary

This trial will test the effects of the drug DCA on brain cancer patients who are undergoing surgery. Patients will be given DCA or a placebo for one week before surgery, and then blood and tumor tissue will be collected and analyzed.

Who is the study for?
Adults aged 18-80 with recurrent Glioblastoma Multiforme (GBM) who have already undergone surgery, radiation, and chemotherapy with temozolomide are eligible. They must not be pre-terminal or pregnant, nor can they have severe liver insufficiency, end-stage renal failure, or be on insulin/sulfonylurea therapy for diabetes.Check my eligibility
What is being tested?
The trial is testing oral Dichloroacetate (DCA) in patients with GBM to establish safe dosing based on genotyping. Participants will either receive DCA or no treatment for one week before their clinically indicated tumor removal surgery.See study design
What are the potential side effects?
Potential side effects of DCA may include lowering blood glucose levels which could lead to hypoglycemia especially in diabetic patients. Since it's metabolized by the liver and cleared by the kidneys, those organs' conditions might affect how the drug works and its safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult between 18 and 80 with a GBM diagnosis, my tumor has come back, and I have symptoms like headaches or seizures. Surgery to remove the tumor is planned.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 weeks post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 weeks post surgery 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 expressed in surgical tissue

Trial Design

2Treatment groups
Active Control
Group I: No Pre-Surgical Dichloroacetate (DCA)Active Control2 Interventions
Subject randomized to start DCA after surgery will do so 12-24 hours postoperatively, depending on their ability to safely receive medication.
Group II: Pre-Surgical Dichloroacetate (DCA)Active Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,316 Total Patients Enrolled
10 Trials studying Glioblastoma
434 Patients Enrolled for Glioblastoma
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
Peter Stacpoole, PhD, MDPrincipal InvestigatorUniversity of Florida

Media Library

Dichloroacetate (DCA) (Metabolic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05120284 — Phase 2
Glioblastoma Research Study Groups: No Pre-Surgical Dichloroacetate (DCA), Pre-Surgical Dichloroacetate (DCA)
Glioblastoma Clinical Trial 2023: Dichloroacetate (DCA) Highlights & Side Effects. Trial Name: NCT05120284 — Phase 2
Dichloroacetate (DCA) (Metabolic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05120284 — Phase 2

Frequently Asked Questions

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

What is the current population size of this research program?

"That is correct. The details on clinicaltrials.gov demonstrate that this experiment, which was initially released on July 1st 2022, is still ongoing. A total of 40 patients are needed from 2 distinct medical centres."

Answered by AI

Has the FDA permitted the non-surgical use of Dichloroacetate (DCA)?

"Our organization at Power graded the safety of No Pre-Surgical Dichloroacetate (DCA) as a 2, given that it is currently in its second phase. This implies there exists some data regarding security but none to prove efficacy."

Answered by AI

Is this research unique or has it been previously explored?

"Since 2020, No Pre-Surgical Dichloroacetate (DCA) has been subject to clinical investigation. Medosome Biotec LLC sponsored the first trial with 34 participants, which granted the drug its Phase 3 approval. At present, three ongoing trials are recruiting patients across 10 cities and one nation."

Answered by AI

Is the age bracket for this experimental research extending beyond twenty years?

"The parameters of this trial necessitate enrolment from individuals between 18 and 80. 36 studies are available to minors, while those over 65 have access to 418 different trials."

Answered by AI

Is enrollment open for this trial at present?

"That is correct. According to clinicaltrials.gov, recruitment for this medical trial began on the 1st of July 2022 and was recently updated on August 26th, 2022. The study seeks 40 individuals from two separate locations."

Answered by AI

What other experiments have been conducted to explore the potential of No Pre-Surgical Dichloroacetate (DCA)?

"Presently, there are 3 running trials on No Pre-Surgical Dichloroacetate (DCA) with 1 in Phase 3. 12 different medical centres across the country have studies involving this drug; however, most of them are located at Stanford University in California."

Answered by AI

Is enrollment open to join this experiment?

"This medical trial is currently enrolling 40 patients, aged 18-80 years old with a glioblastoma diagnosis. All participants must meet several criteria: they will be recruited and studied at 11 ABTC clinical sites, the DCA liquid formulation has been approved by the FDA for oral or feeding tube administration; insulin or sulfonylurea therapy are not permitted but other medications may remain unchanged; male and female adults between 18 - 80 years of age who have experienced GBM recurrence combined with symptomatology (e.g., headache) can apply, having completed standard treatment followed by radiation and temozolomide in"

Answered by AI
~16 spots leftby Jun 2025