A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
Status:
Completed
Trial end date:
2016-09-28
Target enrollment:
Participant gender:
Summary
The subjects will be treated with a single dose of SP-SAP. They will receive the study drug
SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and
required to stay in the hospital for 24 hours for precautionary care. Their vital signs will
be monitored and recorded immediately following the injection. After the catheter has been
removed, the following assessments will be made physical exam including motor and sensory
functions, and electrocardiogram. A neurologist will be available for consultation as needed.
Beginning dose of SP-SAP will be 1 -mcg for the first cohort.
Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into
the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities
between cohorts.
Study duration will be up to 6 months from the start of SP-SAP administration.