| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Safety | Drug: Ascorbate-Meglumine | Phase 1 |
Phase 1, single-center, open-label study in subjects receiving SRS for brain metastases.
The study will consist of 4 principal cohorts (n=3 in each cohort). Each cohort will receive an escalating dose of ascorbate-meglumine as an MRI-detectable adjunctive therapeutic to SRS.
Subjects will complete a planning MRI for SRS with gadolinium- diethylenetriamine penta-acetic acid (GD-DPTA) per standard of care for SRS. Forty-eight hours after the planning MRI, the subjects will complete the study MRI with ascorbate-meglumine contrast agent. Each cohort will receive an escalating dose of ascorbate-meglumine by intravenous administration over 1 hour during the MRI. The total dose of ascorbate-meglumine-will escalate from the first cohort to the next cohort in a sequential manner. During ascorbate-meglumine infusion, MRI scans will be performed to evaluate the contrast effect and PK blood draws will occur at defined time points.
Patients will return for the SRS procedure within 1 week following the planning MRI per standard of care. During SRS, subjects will receive a second dose of ascorbate-meglumine as an adjunctive therapeutic.
Patients will enter into a follow up phase within 2 weeks after the SRS procedure per standard of care.
The primary endpoint is to evaluate the safety of parenteral ascorbate-meglumine as a MRI-detectable adjunctive therapeutic to SRS.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | dose escalation |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging-guided Adjunctive Therapeutic for Stereotactic Radiosurgery |
| Estimated Study Start Date : | December 1, 2021 |
| Estimated Primary Completion Date : | August 1, 2024 |
| Estimated Study Completion Date : | August 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Cohort 1
Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases The first cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.16 g/min for 60 minutes.
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Drug: Ascorbate-Meglumine
Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate, 125 mM ascorbic acid and 125 mM meglumine in sterile water for injection.
Other Name: Vitamin C
|
|
Experimental: Cohort 2
Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases The first cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.31 g/min for 60 minutes.
|
Drug: Ascorbate-Meglumine
Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate, 125 mM ascorbic acid and 125 mM meglumine in sterile water for injection.
Other Name: Vitamin C
|
|
Experimental: Cohort 3
Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases The second cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.63 g/min for 60 minutes.
|
Drug: Ascorbate-Meglumine
Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate, 125 mM ascorbic acid and 125 mM meglumine in sterile water for injection.
Other Name: Vitamin C
|
|
Experimental: Cohort 4
Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases The third cohort of patients will receive ascorbate-meglumine at a dose administration rate of 1.25 g/min for 60 minutes.
|
Drug: Ascorbate-Meglumine
Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate, 125 mM ascorbic acid and 125 mM meglumine in sterile water for injection.
Other Name: Vitamin C
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| United States, North Carolina | |
| Duke Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | John Kirkpatrick, M.D. Ph.D. | Duke Health |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 17, 2019 | ||||
| First Posted Date ICMJE | April 25, 2019 | ||||
| Last Update Posted Date | January 19, 2021 | ||||
| Estimated Study Start Date ICMJE | December 1, 2021 | ||||
| Estimated Primary Completion Date | August 1, 2024 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety, as measured by adverse events [ Time Frame: 1 week after receiving study drug with SRS ] Adverse events will be monitored in patients receiving ascorbate formulated with meglumine during the SRS procedure
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Ascorbate-Meglumine Therapeutic for SRS | ||||
| Official Title ICMJE | Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging-guided Adjunctive Therapeutic for Stereotactic Radiosurgery | ||||
| Brief Summary | Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS). | ||||
| Detailed Description |
Phase 1, single-center, open-label study in subjects receiving SRS for brain metastases. The study will consist of 4 principal cohorts (n=3 in each cohort). Each cohort will receive an escalating dose of ascorbate-meglumine as an MRI-detectable adjunctive therapeutic to SRS. Subjects will complete a planning MRI for SRS with gadolinium- diethylenetriamine penta-acetic acid (GD-DPTA) per standard of care for SRS. Forty-eight hours after the planning MRI, the subjects will complete the study MRI with ascorbate-meglumine contrast agent. Each cohort will receive an escalating dose of ascorbate-meglumine by intravenous administration over 1 hour during the MRI. The total dose of ascorbate-meglumine-will escalate from the first cohort to the next cohort in a sequential manner. During ascorbate-meglumine infusion, MRI scans will be performed to evaluate the contrast effect and PK blood draws will occur at defined time points. Patients will return for the SRS procedure within 1 week following the planning MRI per standard of care. During SRS, subjects will receive a second dose of ascorbate-meglumine as an adjunctive therapeutic. Patients will enter into a follow up phase within 2 weeks after the SRS procedure per standard of care. The primary endpoint is to evaluate the safety of parenteral ascorbate-meglumine as a MRI-detectable adjunctive therapeutic to SRS. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: dose escalation Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Safety | ||||
| Intervention ICMJE | Drug: Ascorbate-Meglumine
Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate, 125 mM ascorbic acid and 125 mM meglumine in sterile water for injection.
Other Name: Vitamin C
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE |
0 | ||||
| Original Estimated Enrollment ICMJE |
12 | ||||
| Estimated Study Completion Date ICMJE | August 1, 2024 | ||||
| Estimated Primary Completion Date | August 1, 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03927625 | ||||
| Other Study ID Numbers ICMJE | Pro00103610 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Chris Lascola, MD, Duke University | ||||
| Study Sponsor ICMJE | Chris Lascola, MD | ||||
| Collaborators ICMJE | Duke University | ||||
| Investigators ICMJE |
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| PRS Account | Duke University | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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