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 ]

The response criteria are based on achievement of a 20% reduction in chronic pain or opioid dose within eight weeks of treatment as assessed by at least two of the measured parameters: VAS "pain bothersomeness." VAS "pain intensity," ODI, SF-36, EQ-5D, BDI, and medication use log. Safe doses of opioids will be determined by referring physician and symptoms are refractory if at maximal safe dose of opioids (not associated with severe side effects), the VAS score remains elevated above 3.


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety Tolerability [ Time Frame: 6 months ]

Analyses will be performed for all subjects having received at least one dose of study drug. The study will use the CTCAE version 4.0 for reporting of non-hematologic adverse events


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