Trial record 1 of 1 for:
03034135
Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma
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| ClinicalTrials.gov Identifier: NCT03034135 |
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Recruitment Status :
Completed
First Posted : January 27, 2017
Last Update Posted : August 7, 2019
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Sponsor:
Cantex Pharmaceuticals
Information provided by (Responsible Party):
Cantex Pharmaceuticals
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Glioblastoma | Drug: Disulfiram/Copper Drug: Temozolomide (TMZ) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma |
| Actual Study Start Date : | March 9, 2017 |
| Actual Primary Completion Date : | July 10, 2018 |
| Actual Study Completion Date : | July 10, 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: DSF-Cu
Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.
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Drug: Disulfiram/Copper
Disulfiram/copper gluconate is taken three times a day. Drug: Temozolomide (TMZ) TMZ is given per standard of care |
Primary Outcome Measures :
- Objective Response Rate [ Time Frame: 6 months ]The percentage of patients with Complete Response or Partial Response according to the RANO criteria.
Secondary Outcome Measures :
- Progression Free Survival [ Time Frame: 6 months ]Proportion of patients that are free from progressive disease
- Overall Survival [ Time Frame: 2 years ]Proportion of patients that are alive
- Toxicity [ Time Frame: 6 months ]Adverse events
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed GBM (WHO grade IV).
- The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the planned start of treatment on this study UNLESS there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent TMZ.
- Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI) [as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3 months from the last dose of TMZ.
- Karnofsky performance status (KPS) of at least 60%.
- Willing to remain abstinent from consuming alcohol.
- Recovered from the toxic effects of prior therapy to < grade 2 toxicity per NCI CTCAE prior to study registration (except lymphopenia).
- Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.
- 11. Females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Exclusion Criteria:
- Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain.
- Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.
- Received more than one course of radiation therapy or more than a total dose of 75 Gy.
- History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.
- Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.
- Fever within 3 days prior to study enrollment.
- Active or severe hepatic or renal disease.
- Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE
- History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications.
- History of Wilson's disease.
- History of hemochromatosis.
- Pregnant or breastfeeding.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034135
Locations
| United States, Michigan | |
| Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| John Theurer Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Lenox Hill Hospital | |
| New York, New York, United States, 10075 | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, Tennessee | |
| Vanderbilt Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112-5550 | |
Sponsors and Collaborators
Cantex Pharmaceuticals
Investigators
| Study Chair: | Jiayi Huang, MD | Washington University School of Medicine in St. Louis |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cantex Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03034135 |
| Other Study ID Numbers: |
CAN-201 |
| First Posted: | January 27, 2017 Key Record Dates |
| Last Update Posted: | August 7, 2019 |
| Last Verified: | July 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Copper Temozolomide Disulfiram |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Alcohol Deterrents Acetaldehyde Dehydrogenase Inhibitors Enzyme Inhibitors |