RecruitingPhase 1NCT00804154

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer

A Phase I Study of the Intrathecal Administration of Resiniferatoxin for Treating Severe Refractory Pain Associated With Advanced Cancer


Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Enrollment

45 participants

Start Date

Aug 14, 2009

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called Resiniferatoxin (RTX) — an extremely potent compound derived from a cactus-like plant — injected into the fluid around the spinal cord (intrathecal space) to treat severe, intractable cancer pain in the lower body. RTX works by permanently destroying the specific nerve fibers that carry pain signals from the waist down, offering potentially long-lasting relief for patients who have failed all other pain treatments. You may be eligible if: - You are 18 years or older - You have advanced cancer that has not responded to standard treatments and you are not currently seeking a cure - You have severe pain (average daily worst pain score of 6 or higher on a 0–10 scale) in the lower body (at or below the T6 chest level) - Multiple standard pain control options (opioids, nerve blocks, radiation, adjuvant medications) have failed or are not tolerated - Your blood counts, clotting values, and kidney function meet minimum thresholds - You are able to stop anticoagulant medications before the procedure - You are able to read, understand, and speak English - You have a responsible adult who can assist you after the procedure through Day 15 You may NOT be eligible if: - Your primary pain is above the T5 dermatome (upper chest, arms, or head) - You have a spinal abnormality, elevated intracranial pressure, or an existing spinal shunt device - You are pregnant or breastfeeding - You have an allergy to chili peppers or capsaicin - You have a heart condition (heart failure, history of fainting, or QTc interval over 450 ms) - You have a history of seizures within the last month or recent opioid toxicity symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntrathecal Resiniferatoxin

phase I, single-site, non-randomized, open-label, dose-escalation study to determine the safety and efficacy of IT RTX in subjects with severe refractory pain due to advanced malignancy


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT00804154


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