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

Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Capable of giving written informed consent to participate in the study before undergoing any screening procedures

• Age greater than (>) 18

• Life expectancy of at least 3 months

• GPA score 0.5 or greater

• A contrast-enhanced brain MRI scan performed within 2 weeks of study registration

• Imaging demonstrates the presence of 1 to 3 intact (not previously irradiated or resected) brain metastases

• Maximum tumor diameter ≤ 3 cm for the largest lesion

Locations
United States
North Carolina
Duke Cancer Center
Durham
Time Frame
Start Date: December 1, 2021
Completion Date: August 1, 2024
Treatments
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.
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.
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.
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.
Sponsors
Collaborators: Duke University
Leads: Chris Lascola, MD

This content was sourced from clinicaltrials.gov

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