Back to resultsTreatment of Metastatic Cancer in Terminally Diagnosed Patients
Primary Purpose
Metastatic Cancer
Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Tempol
Sponsored by
About this trial
This is an expanded access trial for Metastatic Cancer
Eligibility Criteria
Inclusion Criteria:
- metastatic terminally diagnosed cancer
Exclusion Criteria:
-
Sites / Locations
- UCHealth University of Colorado Cancer Center - Anschutz Medical Campus
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05491928
Brief Title
Treatment of Metastatic Cancer in Terminally Diagnosed Patients
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Matrix Biomed, Inc.
4. Oversight
5. Study Description
Brief Summary
The objective is to provide terminally diagnosed patients with a last line of treatment while improving overall quality of life. Tempol can be added to any chemotherapy regimen to potentially reduce side effects and overcome chemoresistance.
Detailed Description
The objective is to provide terminally diagnosed patients assigned to palliative care and palliative chemotherapy a last line treatment with Tempol. In vivo studies have shown Tempol to work synergistically with a number of chemotherapy agents increasing treatment response and reducing chemoresistance. Additionally, Tempol has been shown to provide protection to non-cancerous cells allowing for increased chemotherapy dosing by reducing side effects. Tempol inhibits HIF-1/VEGF among others in cancerous cells while upregulating GSH/NrF2 among others in non-cancerous cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tempol
Other Intervention Name(s)
MBM-0-1 MBM-02
Intervention Description
Tempol will be given as an adjunct to chemotherapy.
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
metastatic terminally diagnosed cancer
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benji Crane
Phone
6264376506
Email
bjcrane@matrixbiomed.com
Facility Information:
Facility Name
UCHealth University of Colorado Cancer Center - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Available
12. IPD Sharing Statement
Citations:
PubMed Identifier
15547722
Citation
Ravizza R, Cereda E, Monti E, Gariboldi MB. The piperidine nitroxide Tempol potentiates the cytotoxic effects of temozolomide in human glioblastoma cells. Int J Oncol. 2004 Dec;25(6):1817-22.
Results Reference
background
Learn more about this trial
Treatment of Metastatic Cancer in Terminally Diagnosed Patients
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