Imaging Acetadote Metabolism in Glioblastoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
This goal of this clinical trial is to evaluate how Acetadote affects metabolism in patients with glioblastoma. Drugs like Acetadote, which affect the level of damage in a cell (oxidative stress), may impact brain tumor metabolism and slow the growth of brain tumors.
The investigators are evaluating how Acetadote affects glioblastoma metabolism by using MRI-based methods and by determining the changes in metabolism in brain tumor tissue resected from patients with a new diagnosis of glioblastoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Glioblastoma
2. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent
3. Age ≥18 years
4. KPS > 70
Disqualifiers
1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment.
2. Subjects must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
3. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
4. Brain metastases
Trial design
Design model
Single group
Treatments tested in this trial
Acetadote
DrugAcetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Acetadote 150 mg/kg IVExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS.
The effect of Acetadote on glioblastoma metabolism will be assessed by measuring cysteine, glutathione, and lactate in glioblastoma through MRS.
Time frame
Day 1 and up to 21 days from Day 1Secondary outcomes
1
To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by LCMS
The effect of Acetadote on glioblastoma metabolism in resected tumor tissue will be measured by Liquid chromatography-mass spectrometry (LCMS).
Time frame
Day 1 and up to 21 days from Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Cumberland Pharmaceuticals
Collaborator
Source ClinicalTrials.gov