CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Disulfiram/Copper +1 moredrug
Likely dose
Disulfiram/copper gluconate three times daily; temozolomide per standard of careAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed glioblastoma (WHO grade IV)
  • ✓Completed RT with concurrent TMZ at least 12 weeks prior, OR pathological verification of recurrence with ≥4 weeks since end of RT+TMZ
  • ✓First unequivocal tumor progression by MRI (RANO criteria) within 3 months of last TMZ dose
  • ✓Karnofsky performance status (KPS) ≥60%
Key exclusion· 9
  • ✕Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or remote disease sites
  • ✕Enrolled in another clinical trial of novel therapy within past 4 weeks
  • ✕More than one prior course of radiation therapy or total dose >75 Gy
  • ✕Allergy/hypersensitivity to temozolomide, dacarbazine, disulfiram, or copper

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03034135
NCT03034135Phase 2Completed
CompareCT.gov

A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma

Cantex Pharmaceuticals·interventional·Posted Jan 27, 2017·Updated Sep 13, 2021

In Brief

A Phase 2 clinical trial evaluating Disulfiram/Copper and Temozolomide (TMZ) for Recurrent Glioblastoma. Completed, enrolled 23 participants across 8 sites.

Detailed Summary

This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Glioblastoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 27, 2017
Enrollment StartMar 9, 2017
Primary CompletionJul 10, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.4 years ago

Interventions

Disulfiram/Copperdrug

Disulfiram/copper gluconate is taken three times a day.

Temozolomide (TMZ)drug

TMZ is given per standard of care