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Scintilla RTX Phase 1b- Uncontrolled Pain Due to Advanced Cancer or Cancer that has Spread - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn whether a study drug called resiniferatoxin (also called RTX) is safe and effective in treating severe pain.

What is the Condition Being Studied?

Uncontrolled pain due to advanced cancer or cancer that has spread (metastasized)

Who Can Participate in the Study?

Adult patients:
- With advanced cancer or metastasis that has not responded to standard therapy and causing uncontrolled pain from the chest down to the lower legs.
- With moderate-to-severe pain
- Who are not currently seeking or receiving potentially curative therapies for cancer (palliative therapy is acceptable).  

For more information about who can be in the study please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Have 8 clinic visits, one of which will require you to stay for up to 10 hours

- Visit 1 will include a physical exam, ECG, blood and urine tests.
-- You will be also be taught how to report your pain score on a diary (log).  

- Visit 2 you will receive the study drug and you will stay in the hospital for up to 8 hours and blood and urine samples will be collected.  
-- Blood and urine sample will be collected.

- Visits 3-8: will include a physical exam, ECG, blood and urine sample and a review of your pain logs.  

You'll be in the study for about 3 and a half months.

Study Details

Full Title
A Multicenter, Open Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated with Cancer
Principal Investigator
Pain Medicine Specialist
Protocol Number
IRB:PRO00082543
NCT:NCT03226574
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698