Clinical Trial: A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
Brief 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.
Detailed Summary:
Screening (-7 days to Day 0)
- Physical exam and medical history;
- Vital signs;
- Blood tests;
- Pain measurements (6 daily pain questionnaires for 7 days prior to receiving study drug);
- Urine tests;
- Pregnancy test;
- Electrocardiogram (EKG), a tracing of the electrical activity of the heart;
- Collection of demographic information (age, sex, ethnic origin);
Study Drug:
SP-SAP will be administered via a spinal injection. Depending on when the subject is enrolled in the study, the dose of SP-SAP will be between 1 and 90 micrograms of SP-SAP
Therapy:
Subject will arrive at the UTSW Eugene McDermott Center for Pain Management 2 hours prior to treatment. The following will take place:
- Physical exam;
- Pain measurements (6 pain questionnaires);
- EKG;
- The subject will have a catheter inserted into their spine and will receive the study drug intrathecally (into their spine). The catheter will remain in their spine for 4 hours. Less than 1 tablespoon of spinal fluid will be collected for research purposes; and
- They will remain in the University of Texas Southwestern Medical Center Hospital for 24 hours for observation as a precaution.
Follow-Up
Sponsor: University of Texas Southwestern Medical Center
Current Primary Outcome: Response Evaluation Criteria [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety Tolerability [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: January 10, 2014
Date Started: January 2014
Date Completion: March 2018
Last Updated: June 7, 2016
Last Verified: June 2016