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Protocol Details

An Open-Label, Phase 1b Safety and Efficacy Trial of Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-Induced Bone Pain

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-N-0175

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 100

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Palliative Care;
Adults;
Cancer Pain;
Nerve Block;
Quality of Life

Recruitment Keyword(s)

None

Condition(s)

Intractable Pain;
Palliative Care;
Neoplasm Metastasis;
Questionnaires & Surveys

Investigational Drug(s)

Resiniferatoxin (RTX)

Investigational Device(s)

None

Intervention(s)

Drug: Resiniferatoxin

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

Participants will keep a log of the pain medications they take after surgery.

Participants will be called 1 week and 2, 3, and 4 months after the injection.

Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after the injection.

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Eligibility

INCLUSION CRITERIA:

1. Male or female subjects must be at least 18 years of age or older.

2. Must be diagnosed with histologically-confirmed cancer-induced bone pain producing intractable chronic pain in the target area (mid thoracic or chest level down to lower extremities) which was poorly responsive to conservative therapies based on patient report, such as analgesic medication management with potent opioids with or without prior radiotherapy, bisphosphonates, or radioisotope therapy. Additionally, pain that is non-responsive to non-opioid drugs in situations where opioids were not tolerated. Conservative therapies do not include invasive treatments, such as neurolytic procedure, including surgical neurolysis, percutaneous regional or neuraxial continuous infusions (whether opioid or local anesthetic), and peripheral neuromodulation or spinal cord stimulation, but may include temporary diagnostic or therapeutic procedures.

3. Must have moderate to severe pain that is not relieved by standard treatments.

4. The chronic pain must result in an average score of at least 5 on the Brief Pain Inventory (BPI) Pain Interference (BPI-PI) Items. The score across the 7 BPI-PI items is averaged: the number (0 to 10) that describes how, during the past week, the subject s pain has interfered with the following: general activity, mood, walking ability, normal work (whether work outside the home or housework), relations with other people, sleep, and enjoyment of life.

5. The subject must have undergone a diagnostic periganglionic injection(s) with a long-acting local anesthetic (e.g., bupivacaine) under fluoroscopic guidance which resulted in at least a 30% temporary pain reduction in the targeted pain region lasting for the expected duration of the local anesthetic used, prior to study drug treatment. Evidence of pain relief by bipuvicaine validates that a ganglia is involved in transmitting the pain signal from the site of cancer to the central nervous system.

6. Must be healthy enough to tolerate study procedures in the judgment of the investigator.

7. Subjects taking aspirin, non-steroidal anti-inflammatory medications, or vitamin supplements that include vitamin E or any prophylactic anticoagulant (including but not limited to Coumadin, heparin, or Xarelto) will be counseled either to stop taking these at least 7 days before surgery or be given instructions on dosing changes if applicable. In addition, if patients are currently taking a Factor Xa inhibitor (such as Xarelto) a hematology consult will be obtained. Subjects must be willing to comply with this requirement, which is standard clinical practice when undergoing elective surgical procedures to avoid surgical and post-surgical bleeding complications.

8. If able to become pregnant or to father a child, agree to use a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy) for the duration of the study. Subjects must be willing and capable of understanding and cooperating with the birth control requirements of the study.

9. Medical clearance from referring physician.

10. Must be willing and able to participate in all study procedures.

11. Must be capable of understanding and cooperating with the requirements of the study.

12. Subjects must be able to understand and complete study-related forms and adequately communicate in English.

13. Subjects must have provided written informed consent which includes signing the institutional review board (IRB)-approved consent form prior to participating in any study-related activity.

14. Must have the capacity to provide informed consent.

EXCLUSION CRITERIA:

1. Subjects must not be undergoing or have plans to undergo any active treatment for their cancer during the study until after the day 30 assessment timepoint, after the RTX injection.

2. Subjects must not have had prior surgical procedures, such as posterior spinal fusions in the area of the injection site that could impair the ability to perform the periganglionic injection.

3. Subjects must not have evidence of a coagulopathy or hemostasis problem as evidenced by the following blood laboratory values within the week prior to the planned injection:

PT/INR > 1.5 times upper limit normal range (ULNR)

PTT > 35 seconds

4. Platelet count less than 50,000 Subjects must not have a total neutrophil count (TNC) < 1500. 1500. The US Clinical Practice Guideline for lumbar puncture is a platelet count of 50,000, which is higher risk for hemorrhage than periganglionic injection.

4.5.Patients with TNC<1500 (neutropenia) may be eligible later if their TNC level becomes greater than 1500 spontaneously or after use of medications stimulating granulocyte production, such as Neupogen (granulocyte colony stimulating factor: G-CSF).

5. Subjects must not be febrile or have other evidence of an infection within 7 days of the planned periganglionic injection.

6. Subjects must not have an allergy or hypersensitivity to chili peppers, capsaicin or radiographic contrast agents.

7. Female subjects must not be pregnant or breastfeeding

8. Subjects with any medical condition that, in the Investigator s opinion, could adversely impact the subject s participation or safety, conduct of the study, or interfere with the pain assessment, such as poorly controlled diabetes or hypertension. Patients can be re-assessed for eligibility if these conditions can be controlled medically.

9. Subjects who participated in a clinical trial of an investigational drug or device within 30 days of screening visit or are scheduled to receive an investigational product while participating in this study.

10. Subjects must not have received invasive treatments, such as a neurolytic procedure, including surgical neurolysis, percutaneous regional or neuraxial continuous infusions (whether opioid or local anesthetic), peripheral neuromodulation or spinal cord stimulation.


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Citations:

Mannes AJ, Brown DC, Keller J, Cordes L, Eckenhoff RG, Caudle RM, Iadarola MJ, Meng QC. Measurement of resiniferatoxin in serum samples by high-performance liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Sep 5;823(2):184-8.

Neubert JK, Mannes AJ, Karai LJ, Jenkins AC, Zawatski L, Abu-Asab M, Iadarola MJ. Perineural resiniferatoxin selectively inhibits inflammatory hyperalgesia. Mol Pain. 2008 Jan 16;4:3. doi: 10.1186/1744-8069-4-3.

Iadarola MJ, Mannes AJ. The vanilloid agonist resiniferatoxin for interventional-based pain control. Curr Top Med Chem. 2011;11(17):2171-9.

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Contacts:

Principal Investigator

Referral Contact

For more information:

John D. Heiss, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Fredric K. Cantor, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 3D20
10 CENTER DR
BETHESDA MD 20814
(301) 451-1184
cantorf@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02522611

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