Study on Dichloroacetate (DCA) for Treating Recurrent Glioblastoma Multiforme (GBM)

Sponsor: University of Florida

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05120284

Provider View

This clinical trial is testing the effects of the drug Dichloroacetate (DCA) in patients with recurrent Glioblastoma Multiforme (GBM) who are scheduled for surgery. The study aims to understand how DCA affects the tumor and involves taking blood and tumor samples during surgery.

Patient Parameters

Program Overview

This study is exploring the use of Dichloroacetate (DCA), a drug taken by mouth, in patients with recurrent Glioblastoma Multiforme (GBM), a type of brain cancer. The trial involves 40 patients who are scheduled for surgery to remove part of their tumor. Half of the participants will receive DCA for one week before their surgery, while the other half will not. The goal is to see how DCA affects the tumor by analyzing blood and tumor samples collected during surgery. The study is being conducted at Johns Hopkins University, Sibley Memorial Hospital, and Wake Forest University.

Description

The purpose of this study is to evaluate how the drug Dichloroacetate (DCA) affects a specific process in brain tumors called PDC phosphorylation. DCA is a medication that can be taken by mouth or through a feeding tube. The study will involve 40 patients with recurrent Glioblastoma Multiforme (GBM) who are scheduled for surgery to remove part of their tumor. Participants will be randomly divided into two groups: one group will receive DCA for one week before surgery, and the other group will not receive DCA. Blood and tumor samples will be collected during surgery to study the effects of DCA. The study is being conducted at Johns Hopkins University, Sibley Memorial Hospital, and Wake Forest University. Patients can continue taking their regular medications, except for those who need insulin or certain diabetes medications. The study aims to ensure that DCA is safe to use with other medications and does not cause harmful interactions.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 80 years with a diagnosis of recurrent Glioblastoma Multiforme (GBM).
  • Scheduled for surgery to remove part of the tumor.
  • Have completed initial standard treatment, including surgery, radiation, and temozolomide (TMZ), unless the tumor is unmethylated.
  • Patients will be recruited from Johns Hopkins University, Sibley Memorial Hospital, and Wake Forest University.
  • Can continue taking medications for other conditions, except for insulin or sulfonylurea therapy.
  • Diabetic patients must have a hemoglobin A1c level of at least 6.0.

Exclusion Criteria

  • Patients with a life expectancy of 2 months or less.
  • Pregnant individuals.
  • Patients taking insulin or sulfonylurea medications for diabetes.
  • Patients with severe kidney failure (GFR ≤ 30 ml/min).
  • Patients with severe liver problems (total bilirubin > 2.0 mg/dl or ALT or AST > 3 times the normal limit).
  • Diabetic patients with a hemoglobin A1c level less than 6.0.

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