INCLUSION CRITERIA:
Patient inclusion criteria are based on inadequate control of pain despite best efforts, including appropriate use of medication(s). Thus, criteria include the following:
1) 18 years or older.
2) Diagnosed with histological documentation of cancer
- progressive disease after standard therapies
- no effective palliative therapy to alleviate pain
- patient is not seeking curative therapies (e.g. chemotherapy, immunotherapy) at this time because concurrent studies may confound assessments of an adverse event.
- this study will not prevent enrollment of the patient in future palliative or curative studies, but patients will be requested to delay enrollment until after the 2- week follow-up appointment. At this point, patients will no longer be discouraged from enrolling in these therapies.
3) Inadequate pain relief at maximally tolerated opioid dose
- dose-limiting side effects
- subjective daily average and worst pain visual analog scale (VAS) rating of pain of greater than or equal to 6
- the use of opioids may include the oral, intravenous, rectal, intramuscular, subcutaneous, inhaled, nasal or sublingual routes of administration. (see 3.1.3 for discussion of VAS selection)
4) Trial(s) of adjuvant pain medications are ineffective or not tolerated
- to include consideration of antidepressant, steroids, local anesthetics or anti-seizure medications
- utilizing guidelines proposed for the treatment of this patient population (e.g. Cancer Pain, Treatment Guidelines for Patients -Version I, January 2001, American Cancer Society).
5) Procedures for managing pain are of limited benefit, not indicated or refused by the patient (i.e. catheter or implantable pump placement, neurolytic procedures including intercostals, superior hypogastric or celiac plexus block).
6) Other methodologies for controlling pain including complementary medicine have been of limited benefit, not indicated or refused by the patient.
7) Patient can have widespread pain but the severe pain must not include the face, jaw and neck (trigeminal ganglion).
EXCLUSION CRITERIA:
No exclusions will be made based on race, gender, or religion. Safe administration is reliant upon the intrathecal delivery of RTX via a catheter. The exclusion criteria are used to screen patients that cannot have a catheter safely placed in the subarachnoid space, such as problems with bleeding, pathology or anatomy of the spinal cord or vertebral column, or that cannot complete the requirements of the study (surveys, tools, imaging). Medications that can be halted for the placement and removal of the catheter, including warfarin, low molecular weight heparin, platelet inhibitors or heparin (per approval from the patient's primary physician) will not exclude a patient from this study. The approach to withholding these medications will be in accordance to the American Society of Regional Anesthesia guidelines (American Society of Regional Anesthesia and Pain Medicine Consensus Conference held during the Annual Spring Meeting on Regional Anesthesia, Chicago, Illinois, April 25-28, 2002).These criteria will be modified if new guidelines are published.
1) Coagulation dysfunction can result from medications (anticoagulants), bone marrow dysfunction or advanced liver disease and will be assessed by laboratory analysis.
a. PT/PTT must be less than 1.5 control. This is a standard accepted value for safely placing intrathecal catheters. Coagulation can be corrected (blood products, Vitamin K, etc.) to be confirmed by blood draw.
b. (CBC) Platelet count (PLT) less than 100K (19). A patient can receive a platelet transfusion but the patient's PLT level must meet this criterion immediately prior to both catheter placement and removal (confirmed by a blood draw).
2) CNS pathology/anatomy will be assessed using imaging techniques (MRI).
- Patients with lesions of the spinal cord/intrathecal space that prevent safe placement of the catheter or prevent flow of CSF will be excluded from the study.
- If the radiologist and neurosurgeon feel that there may be a structural problem with the spinal column (i.e. impending vertebral collapse), the patient will not be enrolled.
-The patient must agree to the MRI examination-patients unwilling or unable to tolerate an MRI with or without sedation will be excluded.
3) Patients currently using implantable epidural or intrathecal devices will be excluded. Patients with a non-utilized or non-functioning device can still be enrolled. If the device has a side-port and clear CSF can be withdrawn, then the device will be used in lieu of intrathecal catheter placement. Patients with intrathecal shunt devices (VP or VA shunts) will not be enrolled.
4) Patients with advanced brain pathology and elevated intracranial pressure (ICP)
5) Patients with allergies to chili peppers or capsaicin
6) Patients who are pregnant
7) Any patient with medical issues that are deemed by the PI to greatly increase risk
8) Patients who are unable to or unwilling to complete the tools/forms.
9) Patients who are unable to arrange for post-treatment observation.
These exclusion criteria are absolute since the theoretical risks of an adverse event are increased.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 11/25/2009