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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

advanced cancer patients with pain

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Industry Sponsor

47 Previous Clinical Trials

1,919 Total Patients Enrolled

National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor

300 Previous Clinical Trials

848,299 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

649,316 Total Patients Enrolled

13 Trials studying Chronic Pain

1,679 Patients Enrolled for Chronic Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open to join this experiment?

"According to clinicaltrials.gov, this medical research is presently enrolling volunteers and has been since August 14th 2009 with the latest update on November 9th 2022."

Answered by AI

What other research endeavors have been undertaken to explore the effects of Intrathecal Resiniferatoxin?

"Currently, there are 4 clinical trials involving Intrathecal Resiniferatoxin being conducted in 11 different locations. Pasadena, California is the primary hub for most of these studies which have yet to reach Phase 3."

Answered by AI

Does Intrathecal Resiniferatoxin pose any risks to human health?

"Due to the limited evidence of safety and efficacy in Phase 1 trials, our team at Power gives Intrathecal Resiniferatoxin a score of 1."

Answered by AI

How many participants are currently engaged in this trial?

"Affirmative. Clinicaltrials.gov records demonstrate that this medical investigation, which was initially posted on August 14th 2009, is currently enrolling volunteers. Approximately 45 participants must be sourced from 2 separate clinical locations."

Answered by AI

Is this trial the inaugural investigation of its type?

"Since 2009, Sorrento Therapeutics Inc. has sponsored research into intrathecal resiniferatoxin and the drug's Phase 1 approval was granted after a trial of 45 participants. Currently, there are 4 live clinical trials studying this therapy in 7 cities across one nation."

Answered by AI

Who else is applying?

What site did they apply to?

National Institutes of Health Clinical Center

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Hoping to get help with my constant pain . Say it's fibromygia bit when winter gets here I can't hardly walk. So I'm willing to try anything to help me an anyone else it can benefit in long run.

PatientReceived no prior treatments