Dichloroacetate for Glioblastoma

(DCA Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Patients must be able to provide written informed consent

I have recurring brain cancer with symptoms and surgery planned to remove part of the tumor.

I can swallow liquids without difficulty.

Exclusion Criteria

I do not have any severe illnesses that could interfere with the study.

I have recovered from previous cancer treatment side effects, except for hair loss.

Patients receiving any other investigational agents for brain tumor are ineligible

Participant Groups

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.

Group I: Arm 2 - NO Pre-surgical dosing Experimental Treatment 1 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 dosing Experimental Treatment 1 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lead Sponsor

Food and Drug Administration (FDA) Collaborator

References