drugset / Trial / NCT02715609

Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

NCT02715609

Phase 1/2 Completed 35 enrolled Washington University School of Medicine
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

EvaluationDrugModalityDoseRoute
Subject Copper Gluconate Small molecule
Subject Disulfiram Small molecule 250 mg
Subject Disulfiram Small molecule 375 mg
Background Temozolomide Small molecule Oral

Indications