drugset / Trial / NCT02715609
Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Non-randomizedSequentialOpen-labelTreatment
Summary
The proposed phase I/II study of disulfiram (DSF) for patients with presumed glioblastoma multiforme (GBM) based on magnetic resonance imaging (MRI) or biopsy, including administration before surgery and during adjuvant chemoradiotherapy. Patients will be treated with 3 days of preoperative DSF/copper (Cu) prior to their surgery (or biopsy), which will be followed by collection of tumor samples during surgery for analysis of drug uptake. After the surgery, patients will receive standard radiation therapy (RT) and temozolomide (TMZ) with the addition of concurrent DSF/Cu.
Timeline
- Start
- 2016-06-15
- Primary completion
- 2024-05-12
- Completion
- 2024-05-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copper Gluconate | Small molecule | — | — |
| Subject | Disulfiram | Small molecule | 250 mg | — |
| Subject | Disulfiram | Small molecule | 375 mg | — |
| Background | Temozolomide | Small molecule | — | Oral |