Actively Recruiting
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2026-05-01
45
Participants Needed
1
Research Sites
912 weeks
Total Duration
On this page
Sponsors
N
National Institute of Dental and Craniofacial Research (NIDCR)
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transmit pain information. People at least 18 years of age with severe pain from advanced cancer at or below the level of the chest that cannot be controlled with standard treatments may be eligible for this study. Participants undergo the following procedures: Pretreatment Visit Before beginning treatment with RTX, patients give a medical history and undergo a physical examination that includes: * Electrocardiogram (EKG) * Blood draw * Urinalysis * Neurological examinations * Peak expiratory flow rate (PEFR) * Eye examination * MRI * Urology assessment * Pregnancy test, when appropriate * Questionnaires to collect information on health, personality, mood, pain levels and symptoms. 2-Day Hospitalization Patients are hospitalized for 2 days for RTX injection and monitoring, as follows: * RTX injection: RTX is injected in the operating room under general anesthesia. It is given through a catheter placed in the patient s spine. The catheter is also used to obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord. The fluid is examined to assess drug effects and side effects, chemical changes in the content of the CSF associated with RTX, and how RTX is handled by the body. * Post-injection monitoring, including: * Surveys about symptoms such as pain or weakness * Neurological examinations * Blood and CSF sampling * EKG * AEs Outpatient followup * Vitals * Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after the injection * MRI scans of the head and back, Urology assessment and PEFR on day 15 after the injection * Eye examination * Follow-up phone calls monthly for 6 months
CONDITIONS
Official Title
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical and histological diagnosis of cancer with disease not responding adequately to standard therapies
- Not currently seeking or receiving curative cancer therapies like chemotherapy or immunotherapy
- Mean daily worst pain score of 6 or higher at or below the chest level related to cancer
- Insufficient relief from or intolerance to other pain control methods including opioids, adjuvant medications, neurolytic interventions, complementary therapies, or radiation
- Reasonable expectation to complete the study through the 30-day follow-up
- Medical clearance from referring physician
- Approval for study inclusion by principal investigator, oncologist or surgeon, and palliative care team member
- International normalized ratio (INR) less than 1.5 and partial thromboplastin time (PTT) within reference range
- Platelet count at least 50,000/mm3, transfused if necessary to 100,000/mm3 before dosing
- Ability to stop anticoagulant and antiplatelet therapies before and during catheter placement
- Ability and willingness to undergo eye examination
- Ability to read, speak, and understand English and complete study forms
- For women of childbearing potential and men with partners of childbearing potential, willingness to use effective contraception during study
- Availability of a responsible adult to assist through Day 15 visit
- Ability to assign Durable Power of Attorney for research and medical care at NIH
You will not qualify if you...
- Primary pain source from areas at or above the T5 dermatome
- Moderate to severe pain from causes other than cancer or its treatment
- Spinal cord or intrathecal abnormalities increasing risk or interfering with cerebrospinal fluid flow
- Advanced brain pathology or elevated intracranial pressure
- Presence of intrathecal shunt devices
- Planned initiation or significant change of palliative anti-tumor therapy before Day 15 visit
- Allergy to chili peppers or capsaicin
- Contraindications to MRI or MRI contrast
- Pregnant or lactating females
- Clinically significant conditions interfering with study participation or safety
- Planned use of other investigational treatments within 30 days after dosing
- History of heart failure or unexplained fainting
- EKG abnormalities with QTc interval over 450 milliseconds
- Known family history of long QT syndrome
- Uncorrectable abnormal electrolyte levels
- Urinary retention or skin ulceration unresolved by treatment
- Seizure activity in previous month
- Symptoms of opioid toxicity in past month such as myoclonus, seizures, or hallucinations
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
John D Heiss, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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