Clinical Trial: Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: A Multicenter, Open-Label, Phase 1b Safety and Efficacy Trial of Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-Induced Bone Pain
Brief Summary:
Background:
Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to anxiety, depression, and reduced mobility and quality of life. Researchers believe a research drug called resiniferatoxin (RTX) may be able to help.
Objective:
To learn whether RTX is safe and can reduce cancer induced bone pain.
Eligibility:
People ages 18 and older with CIBP that is not relieved by standard treatments
Design:
Participants will have up to 6 outpatient visits over about 7 months. These will include:
Medical history
Physical exam
Blood and urine tests.
Thermal testing: a disk placed on the skin to test ability to sense temperature in and around the area of pain
Chest x-ray
EKG: stickers are placed on the chest to measure heart signals
ECG: measures electrical activity of the heart
Participants will have 1 inpatient visit lasting 2-4 days. This will include:
Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray contrast.
A needle is passed through the skin of the back to inject the RTX.
Cancer-induced bone pain (CIBP) is a common clinical problem.1 While primary osteosarcoma is relatively uncommon, bone metastases frequently cause cancer-related pain with metastatic spread to bone in 60-84% of cases. 2 Resiniferatoxin (RTX) is an ultrapotent agonist analog of capsaicin that targets a receptor expressed on specific dorsal root sensory ganglia (DRG) neurons and is expected to reduce pain within the targeted zone. The overall program goal is to develop a new treatment for intractable chronic pain below the mid-thoracic level resulting from CIBP that has not been controlled with conservative treatments.
Primary Objectives
To determine the maximum tolerated dose (MTD) of RTX when injected near one or more DRGs, and to characterize its safety/toxicity profile and identify any dose-limiting toxicity (DLT).
Study Population
Up to 30 adult subjects total across all sites are estimated to be necessary for enrollment in order to have up to 16 subjects who will receive RTX and provide study-related assessment results through the 30-day time point.
Design
The study is a multicenter, open-label Phase 1b dose escalation safety and efficacy trial for adult subjects with intractable pain due to CIBP below the mid-thoracic level who meet all other eligibility criteria.
Subjects who have undergone the informed consent (IC) process and signed the approved IC form for the study will be assigned a Screen # (S1, S2, etc.). Those subjects who meet all inclusion and exclusion criteria will undergo various study procedures and then be scheduled for the unilateral periganglionic (PG) DR
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Current Primary Outcome: The primary outcome is to achieve a dose-response relationship for safety [ Time Frame: 30, 60, 90, and 180 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: substantially reduced pain; improved pain relief; substantially reduced concomitant opioid analgesic consumption; improved quality of life [ Time Frame: 30, 60, 90, and 180 days ]
Original Secondary Outcome: Same as current
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: August 12, 2015
Date Started: August 6, 2015
Date Completion: December 31, 2018
Last Updated: May 12, 2017
Last Verified: October 12, 2016
