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NCT02715609 · ClinicalTrials.gov registry record · Phase 1
Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
A Phase 1 study of Glioblastoma Multiforme, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT02715609: Completed Phase 1 study of Glioblastoma Multiforme, sponsored by Washington University School of Medicine.
NCT02715609 is a Phase 1 study of Glioblastoma Multiforme that has completed, run by Washington University School of Medicine. The registered enrollment target is 35 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02715609, a Phase 1 study of Glioblastoma Multiforme, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
* The maximum tolerated dose (MTD) of DSF is defined as the dose level at which 20% of the cohort experience dose-limiting toxicity (DLT) within 18 weeks from start of RT (or 12 weeks from the end of RT if there is a delay in RT). MTD is assessed from the first dose of DSF in combination with TMZ and RT; patients will not be assessed for DLT during the pre-surgery period when they are receiving the lead-in doses of DSF. * A DLT is defined as a clinically significant adverse event or abnormal lab
Conditions Studied
Interventions
- DRUG Temozolomide
- RADIATION Radiation
- PROCEDURE Surgery
- DRUG Disulfiram
- DRUG Copper Gluconate
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2016-06-15 |
| Est. Completion | 2024-05-12 |
| Phase | Phase 1 |
What the finished NCT02715609 record still lists
NCT02715609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT02715609 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT02715609 about?
NCT02715609 is a clinical study titled "Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma". 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/copp...
What is the current status of trial NCT02715609?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2016-06-15. Estimated completion is 2024-05-12.
What conditions does trial NCT02715609 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT02715609?
The interventions under investigation include: Temozolomide (DRUG), Radiation (RADIATION), Surgery (PROCEDURE), Disulfiram (DRUG), Copper Gluconate (DRUG).
Who is sponsoring clinical trial NCT02715609?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02715609 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02715609's enrollment target sits among peer trials
35 56th of 88 higher than 32 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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