A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02036281|
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : May 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Terminally Ill Histologically-confirmed Advanced Cancer Pain, Intractable||Drug: Substance P-Saporin||Phase 1|
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);
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
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);
- 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 will occur weekly for 8 weeks and then monthly for 4 months as needed.
During these visits the following will take place:
- Physical exam (including sensory and motor skills) and medical history;
- Vital signs;
- Two tablespoons of blood will be drawn from your arm by needle stick for blood tests;
- Pain measurements (6 pain questionnaires);
- Urine tests; and
- Electrocardiogram (EKG), a tracing of the electrical activity of the heart.
The subject will be asked to keep a diary to record any nausea and vomiting as well as a medication log to record the pain medications and dosage that they take between visits.
Each visit will take approximately 2 hours to complete
4 Month Follow-Up Informational data on the level of pain, adverse events, and sensory and motor function will be collected for the remaining 4 months of the study or until time of death. This information may be collected via patient diary, office visit or telephone interview.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 28, 2016|
|Actual Study Completion Date :||September 28, 2016|
Experimental: SP-SAP ARM
The first subject will be enrolled in the 1-mcg SP-SAP cohort. A percutaneous intraspinal catheter will be placed at the L5-S1 interspace and the catheter advanced 4-5 cm into the intrathecal space under fluoroscopic guidance. To confirm location, CSF will be aspirated and radioopaque contrast dye injected. 1-mL study drug will be mixed with 1-mL patient CSF fluid and administered intrathecally via the catheter. The catheter will be flushed with 1 mL bolus of saline. Four hours after injection (+15 min), the catheter will be removed and the exit site treated with Neosporin ointment and sterilely dressed. Subjects will be monitored in the recovery room for 4 hours and in the hospital for 24 hours and discharged home. Patients only receive a single IT dose.
Drug: Substance P-Saporin
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036281
|United States, California|
|University of California, San Diego Mores Cancer Center|
|La Jolla, California, United States, 92093-0698|
|United States, Texas|
|UT Southwestern Medical Center Simmons Comprehensive Cancer Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Arthur Frankel, MD||UT Southwestern Medical Center|