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Trial record 24 of 961 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain

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ClinicalTrials.gov Identifier: NCT02522611
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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.

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.


Condition or disease Intervention/treatment Phase
Intractable Pain Palliative Care Neoplasm Metastasis Questionnaires &Amp; Surveys Drug: Resiniferatoxin Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1b Safety and Efficacy Trial of Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-Induced Bone Pain
Study Start Date : August 12, 2015
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Arm Intervention/treatment
Experimental: Resiniferatoxin
Patient receives one dose of Resiniferatoxin intrathecally
Drug: Resiniferatoxin
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.




Primary Outcome Measures :
  1. The primary outcome is to achieve a dose-response relationship for safety [ Time Frame: 30, 60, 90, and 180 days ]

Secondary Outcome Measures :
  1. substantially reduced pain; improved pain relief; substantially reduced concomitant opioid analgesic consumption; improved quality of life [ Time Frame: 30, 60, 90, and 180 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522611


Contacts
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Contact: Fredric K Cantor, M.D. (301) 451-1184 cantorf@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: John D Heiss, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02522611     History of Changes
Other Study ID Numbers: 150175
15-N-0175
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: September 24, 2018

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Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Palliative Care
Adults
Cancer Pain
Nerve Block
Quality of Life

Additional relevant MeSH terms:
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Neoplasm Metastasis
Pain, Intractable
Neoplastic Processes
Neoplasms
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms