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Neurotoxin

Resiniferatoxin for Chronic Pain in Advanced Cancer

Phase 1

Recruiting

Led By John D Heiss, M.D.

Research Sponsored by National Institute of Dental and Craniofacial Research (NIDCR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Ability to stop any anticoagulant (e.g., Coumadin) and antiplatelet therapies (e.g., aspirin) before and during IT catheter placement according to accepted medical guidelines

Must not have

Primary pain source from anatomical regions at T5 dermatome or above

Have a history of heart failure or unexplained fainting (syncope)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7, day 15, day 68, day 188

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine the safety of giving the experimental drug, resiniferatoxin, to treat severe pain in patients with advanced cancer.

Who is the study for?

Adults over 18 with severe pain from advanced cancer below the chest level, uncontrolled by standard treatments. Participants must not be on curative cancer therapy but can continue established palliative care. They should have a high daily pain score, be able to complete follow-ups for 30 days, and agree to use contraception if applicable. Exclusions include those with certain medical conditions or devices, pregnant women, and those allergic to chili peppers or capsaicin.

What is being tested?

The trial tests Resiniferatoxin (RTX), an experimental drug derived from a plant similar to hot pepper's active ingredient. It aims at relieving severe cancer-associated pain by destroying nerves that transmit pain signals. The study involves pretreatment assessments, RTX injection under anesthesia during hospitalization with monitoring of symptoms and side effects through blood draws and MRIs followed by outpatient follow-up visits.

What are the potential side effects?

Potential side effects may include damage to nerve tissues leading to changes in sensation or motor function, reactions related to the spinal injection such as headache or backache, general anesthesia risks during administration of RTX, and possible inflammatory responses due to the destruction of nerve cells transmitting pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can stop taking blood thinners before and during my catheter placement.

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My cancer hasn't improved with standard treatments, confirmed by a pathology report.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My main pain source is above my mid-chest area.

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I have had heart failure or episodes of unexplained fainting.

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I have ongoing issues with not being able to empty my bladder fully despite treatments.

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I have a skin ulcer that hasn't healed with treatment.

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My family has a history of long QT syndrome.

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I have had seizures in the last month.

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I experience moderate to severe pain not related to my cancer or its treatment.

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I have had symptoms like muscle jerks, seizures, or hallucinations due to opioid use in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7, day 15, day 68, day 188

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7, day 15, day 68, day 188

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, day 15, day 68, day 188 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Investigate the safety and efficacy of RTX administered intrathecally in subjects with severe refractory pain associated with advanced cancer along with ED100, the MTD, or the maximum dose administered, whichever is achieved first during dose es...

Secondary study objectives

measures will be other surveys of pain, including an assessment of worst daily pain by the visual analog scale, and assessments of function and quality of life.