Recurrent GlioblastomaPhase 2NCT03034135
Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma
A Phase 2 study testing Disulfiram/Copper and Temozolomide (TMZ) in people with Recurrent Glioblastoma, run by Cantex Pharmaceuticals at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Disulfiram/Copper and Temozolomide (TMZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 8 sitesUnited States
- Study dates
- 9 Mar 2017to 10 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Cincinnati
Cincinnati, Ohio, 45220
Baylor University Medical Center
Dallas, Texas, 75246
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37212
Lenox Hill Hospital
New York, New York, 10075
Beaumont Hospital
Royal Oak, Michigan, 48073
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
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.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Disulfiram/Copper, Temozolomide (TMZ)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disulfiram/CopperDrug
Disulfiram/copper gluconate is taken three times a day.
Temozolomide (TMZ)Drug
TMZ is given per standard of care
| Study group | Role | What they receive |
|---|---|---|
| DSF-Cu | Experimental | Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Receives: Drug: Disulfiram/Copper; Drug: Temozolomide (TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Progression Free Survival
Percentage of patients that are free from progressive disease per RANO criteria
Measured: 6 months
Overall Survival
Percentage of patients that are alive
Measured: 6 months and 12 months
Number of Participants With Serious Adverse Events
Number of Participants with Grade 3 and 4 serious adverse events
Measured: 14 months
Median Progression Free Survival
Duration of progression free survival according to RANO criteria
Measured: 12 months
Median Duration of Overall Survival
Duration of overall survival for patients that are alive
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start9 Mar 2017
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiayi Huang, MD, Study chair, Washington University School of Medicine in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034135
- Sponsor's protocol ID
- CAN-201
- Status last verified
- Jul 2019
- First submitted
- 25 Jan 2017
- Last updated
- 13 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 30771200
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03034135
- Acronym / sponsor ID
- CAN-201
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cantex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSF-Cu | Experimental | Drug: Disulfiram/Copper, Drug: Temozolomide (TMZ)Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disulfiram/CopperDisulfiram/copper gluconate is taken three times a day. | Drug | DSF-Cu |
| Temozolomide (TMZ)TMZ is given per standard of care | Drug | DSF-Cu |
Primary outcome
Objective Response Rate
Time frame: 6 months
ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.
5 secondary outcomes
Progression Free Survival
Time frame: 6 months
Overall Survival
Time frame: 6 months and 12 months
Number of Participants With Serious Adverse Events
Time frame: 14 months
Median Progression Free Survival
Time frame: 12 months
Median Duration of Overall Survival
Time frame: 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30771200Huang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayi Huang, MD study chair
Washington University School of Medicine in St. Louis
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disulfiram/Copper and Temozolomide (TMZ) in people with Recurrent Glioblastoma, run by Cantex Pharmaceuticals at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.