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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSF-Cu | Experimental | Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disulfiram/Copper | Drug | Disulfiram/copper gluconate is taken three times a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Percentage of patients that are free from progressive disease per RANO criteria | 6 months |
| Overall Survival | Percentage of patients that are alive |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiayi Huang, MD | Washington University School of Medicine in St. Louis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30771200 | Derived | Huang J, Chaudhary R, Cohen AL, Fink K, Goldlust S, Boockvar J, Chinnaiyan P, Wan L, Marcus S, Campian JL. A multicenter phase II study of temozolomide plus disulfiram and copper for recurrent temozolomide-resistant glioblastoma. J Neurooncol. 2019 May;142(3):537-544. doi: 10.1007/s11060-019-03125-y. Epub 2019 Feb 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSF-Cu | Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2016 |
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| Temozolomide (TMZ) |
| Drug |
TMZ is given per standard of care |
|
| 6 months and 12 months |
| Number of Participants With Serious Adverse Events | Number of Participants with Grade 3 and 4 serious adverse events | 14 months |
| Median Progression Free Survival | Duration of progression free survival according to RANO criteria | 12 months |
| Median Duration of Overall Survival | Duration of overall survival for patients that are alive | 14 months |
| St Louis |
| Missouri |
| 63110 |
| United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45220 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37212 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112-5550 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Disulfiram and Copper Gluconate | Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate | ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria. | Posted | Count of Participants | Participants | 6 months |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Percentage of patients that are free from progressive disease per RANO criteria | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Percentage of patients that are alive | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months and 12 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events | Number of Participants with Grade 3 and 4 serious adverse events | Posted | Count of Participants | Participants | 14 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Median Progression Free Survival | Duration of progression free survival according to RANO criteria | Posted | Median | 95% Confidence Interval | months | 12 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Median Duration of Overall Survival | Duration of overall survival for patients that are alive | Posted | Median | 95% Confidence Interval | months | 14 months |
|
|
14 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Eligible patients must have progressed after standard chemoradiotherapy and within 3 months of the last dose of TMZ. | 14 | 23 | 2 | 23 | 0 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatobiliary disorders | Hepatobiliary disorders | Liver | Systematic Assessment | Liver enzyme elevation |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Marcus MD | Cantex Pharmaceuticals | 9543153660 | smarcus@cantex.com |
| Aug 16, 2021 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C000726772 | disulfiram-copper |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories |
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| 6 months |
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| 12 months |
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