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New treatment option for Intractable Pain
Official title Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
ClinicalTrials.gov ID: NCT00804154
What this study is testing
What is Intrathecal Resiniferatoxin?
Intrathecal Resiniferatoxin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for intractable pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Subject are based on inadequate control of pain despite best efforts, including appropriate use of analgesic medications. To be enrolled in the...
- Age 18 years or older.
- Clinical and histological diagnosis of cancer with disease that has not adequately responded to standard therapies. A pathology report documenting...
- Subject not currently seeking or receiving potentially curative therapies for cancer (e.g., chemotherapy or immunotherapy). Curative cancer therapy...
- Mean daily worst pain NRS score of greater than or equal to 6 for pain at or below the T6 dermatome (level of the chest) that is associated with a...
You likely can't join if
- people will be excluded from the study if they meet any of the following criteria:
- Primary pain source from anatomical regions at T5 dermatome or above.
- Pain due to causes other than cancer or its treatment that is moderate to severe in intensity.
- Anatomic abnormality or pathology of the spinal cord and/or IT space on magnetic resonance imaging (MRI) that could increase the risk of adverse...
- Evidence of advanced brain pathology or elevated intracranial pressure as determined by symptoms, history, physical examination (including...
- Presence of an IT shunt device (e.g., ventriculo-peritoneal and ventriculo-atrial shunts).
See the full eligibility criteria
Who can join
- Subject are based on inadequate control of pain despite best efforts, including appropriate use of analgesic medications. To be enrolled in the study, people must meet all of the following criteria:
- Age 18 years or older.
- Clinical and histological diagnosis of cancer with disease that has not adequately responded to standard therapies. A pathology report documenting malignancy is required.
- Subject not currently seeking or receiving potentially curative therapies for cancer (e.g., chemotherapy or immunotherapy). Curative cancer therapy may be sought after the Day 15 clinic visit, and palliative anti-tumor...
- Mean daily worst pain NRS score of greater than or equal to 6 for pain at or below the T6 dermatome (level of the chest) that is associated with a malignant disease. The mean score must be derived from recordings on at...
- Alternative methods of pain control are not sufficiently effective, not indicated, not tolerated, and/or refused by the subject, as determined by the Pain and Palliative Care Service (PPCS). Alternative methods of pain...
- Prior neurolytic interventions (including intercostal, superior hypogastric, or celiac plexus blocks)
- Complementary medicine approaches
- Transcutaneous electric nerve stimulation
- Radiation therapy
- Reasonable expectation that the subject will be able to complete the study through the 30-day follow-up.
- Medical clearance from referring physician consisting of a statement indicating an adequate recovery period from other previous trials/medication.
- Formal review of the subject s medical records and written approval for his/her inclusion in the study by 3 separate persons:
- Principal Investigator (PI) or an Associate Investigator (AI)
- Medical oncologist or oncologic surgeon.
- A member of the PPCS at the NIH or institution s equivalent at other sites. 10\. International normalized ratio (INR; from prothrombin time [PT]) \< 1.5 and partial thromboplastin time (PTT) less than or equal to the...
- hormonal contraception (birth control pills, injected hormones, or vaginal ring),
- intrauterine device,
- barrier methods (condom or diaphragm) combined with spermicide, or
- surgical sterilization (hysterectomy, tubal ligation, or vasectomy). 15\. Availability of a responsible adult to assist with activities of daily living as needed for the subject through the Day 15 visit. 16\. Ability to...
What rules you out
- people will be excluded from the study if they meet any of the following criteria:
- Primary pain source from anatomical regions at T5 dermatome or above.
- Pain due to causes other than cancer or its treatment that is moderate to severe in intensity.
- Anatomic abnormality or pathology of the spinal cord and/or IT space on magnetic resonance imaging (MRI) that could increase the risk of adverse effects of catheter placement or interfere with CSF flow.
- Evidence of advanced brain pathology or elevated intracranial pressure as determined by symptoms, history, physical examination (including neurological and eye examination), and/or MRI.
- Presence of an IT shunt device (e.g., ventriculo-peritoneal and ventriculo-atrial shunts).
- Anticipating initiation of palliative anti-tumor therapy or significant changes to current palliative anti-tumor therapy before completion of the Day 15 visit.
- Documented allergy to chili peppers or capsaicin (e.g., hives, wheal).
- Contraindication to MRI or MRI contrast.
- Female people who are pregnant or lactating.
- Clinically significant disorder or condition that might interfere with study participation or greatly increase safety risk to the subject, as judged by a study investigator.
- Planned use of another investigational agent, therapy, or device within 30 days after dosing.
- Have a history of heart failure or unexplained fainting (syncope).
- Have an EKG abnormality in which the baseline QTc interval exceeds 450 milliseconds.
- Have a known family history of long QT syndrome.
- Have abnormal electrolyte levels (i.e., low potassium) that cannot be corrected.
- Have urinary retention that does not resolve with medical or surgical treatment.
- Have skin ulceration that does not resolve with medical or surgical treatment.
- Have a history of seizure activity in the previous month.
- Have experienced symptoms of opioid toxicity in the past month (i.e. myoclonus, seizures, and/or hallucinations)
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.