A Phase 2 study of BPM31510 with Vitamin K1 in subjects with newly diagnosed glioblastoma (GB) (CTMS# 24-0130)
Lay Description
This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of radiation therapy (RT) and concurrent temozolomide (TMZ) chemotherapy for patients with newly diagnosed glioblastoma (GB).
Category
- Cancers and Other Neoplasms
- IRB Number
- STUDY00001094
- NCT Number
- NCT04752813
Eligibility
- Eligible Ages
- 18
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Patients with newly diagnosed pathologically verified GB (by the World Health Organization 2021 criteria or using molecular features defined in C-IMPACT, update 6) (26) with any evidence of residual disease (enhancing or fast fluid-attenuated inversion-recovery [FLAIR]).
2. No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
Exclusion Criteria
History of clinically significant tumor-related cerebral hemorrhage.
2. Patients with multicentric disease defined by tumors which have multiple discrete areas of contrast-enhancing tumor without connecting T2/FLAIR signal abnormality.
3. Patients with diffuse leptomeningeal disease.
4. Patients who are not eligible for definitive surgical resection.
5. Patients on decadron daily dosing more than 2 mg.
Study Design
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Principal Investigator
Andrew Brenner