Intractable Pain

Palliative Care

phase I, single-site, non-randomized, open-label, dose- escalation study to determine the safety and efficacy of IT RTX in subjects with severe refractory pain due to advanced malignancy

Intrathecal Resiniferatoxin

National Institutes of Health Clinical Center, 9000 Rockville Pike

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer

A Phase I Study of the Intrathecal Administration of Resiniferatoxin for Treating Severe Refractory Pain Associated With Advanced Cancer

Dose escalation decisions are based on both effectiveness (as assessed by mean worst pain on the NRS) and DLT. The dose escalation population will include all subjects who are dosed, complete the NRS, and have the DLT assessments from baseline through Day 15. Subjects who are not evaluable for dose escalation will be replaced.

The secondary outcome variables will be summarized over time by dose cohort as appropriate for the outcome measure. Absolute and percentage change in the NRS and VAS pain scores between the pre- and post-RTX dosing assessments (baseline period and study Days 8 through 14, respectively) will also be summarized.

ariocarpus/asthenia

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer

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