Terminally IllPhase 1NCT02036281
A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
A Phase 1 study testing Substance P-Saporin in people with Terminally Ill and Histologically-confirmed Advanced Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminally Ill, Histologically-confirmed Advanced Cancer, Pain, Intractable
- What is being tested?
- Substance P-Saporin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to 28 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Signed informed consent
- Terminally ill cancer patients with intractable chronic pain in the pelvis, lower abdomen, back, or spine. "Terminal" refers to ≤ six-month life expectancy. "Intractable" is defined as pain uncontrolled with medications or procedures.
- Minimal expected survival time of one month
- ECOG Performance status of 0 - 3
- Able to verbally report pain
Show all 10Show fewer
- Able to indicate pain on a VAS
- Able to perform motor/sensory tests
- Able to undergo a 4-h intrathecal catheter placement
- Other therapeutic and palliative options have been exhausted
Who cannot join
- Concurrent therapy with an investigational agent
- Concurrent radiation or chemotherapy
- Pregnancy or failure to use effective contraception in fertile males or females, and breast-feeding females. For all female patients of child-bearing potential, a negative pregnancy test (serum or urine) within ten days before start of the study treatment must be obtained. Female patients must agree to use effective contraception, or must be surgically sterile, or must be postmenopausal. Acceptable forms of birth control are: spermicide with condom, diaphragm, or cervical cap, IUD-intrauterine device, birth control pills, or abstinence. The rhythm method or Plan B are not considered acceptable forms of birth control. Male patients must agree to use effective contraception or be surgically sterile.
- Diagnosis of intractable chronic pain of the chest, head, neck or upper extremities.
- Active infection or ulcer at the lumbar injection site
- Inability to receive lumbar intrathecal injection because of other factors
Show all 9Show fewer
- Diagnosis of meningitis or encephalitis
- Other severe, acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or, in the judgment of the investigator, would make the patient inappropriate for the study
- Comorbidities at particular risk (i.e., CNS, CNS metastases, hydrocephalus or coagulopathy)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern Medical Center Simmons Comprehensive Cancer Center
Dallas, Texas, 75390
University of California, San Diego Mores Cancer Center
La Jolla, California, 92093-0698
About this study
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.
Read more
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.
Read the detailed description
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 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.
- Being tested
- Substance P-Saporin
- Keywords
- Terminally ill , histologically-confirmed advanced cancer, Pain unrelieved by opioids
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance P-SaporinDrug
| Study group | Role | What they receive |
|---|---|---|
| SP-SAP ARM | Experimental | 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. Receives: Drug: Substance P-Saporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Evaluation Criteria
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.
Measured: 8 weeks
Secondary outcomes (1)
Safety Tolerability
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminally IllStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Frankel, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036281
- Sponsor's protocol ID
- STU 102013-010
- Status last verified
- May 2018
- First submitted
- 10 Jan 2014
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
- ClinicalTrials.gov ID
- NCT02036281
- Acronym / sponsor ID
- STU 102013-010
- Keywords
- Terminally ill , histologically-confirmed advanced cancer, Pain unrelieved by opioids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SP-SAP ARM | Experimental | Drug: Substance P-SaporinThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Signed informed consent
- Terminally ill cancer patients with intractable chronic pain in the pelvis, lower abdomen, back, or spine. "Terminal" refers to ≤ six-month life expectancy. "Intractable" is defined as pain uncontrolled with medications or procedures.
- Minimal expected survival time of one month
- ECOG Performance status of 0 - 3
Key exclusion criteria (9 listed)
- Concurrent therapy with an investigational agent
- Concurrent radiation or chemotherapy
- Pregnancy or failure to use effective contraception in fertile males or females, and breast-feeding females. For all female patients of child-bearing potential, a negative pregnancy test (serum or urine) within ten days before start of the study treatment must be obtained. Female patients must agree to use effective contraception, or must be surgically sterile, or must be postmenopausal. Acceptable forms of birth control are: spermicide with condom, diaphragm, or cervical cap, IUD-intrauterine device, birth control pills, or abstinence. The rhythm method or Plan B are not considered acceptable forms of birth control. Male patients must agree to use effective contraception or be surgically sterile.
- Diagnosis of intractable chronic pain of the chest, head, neck or upper extremities.
- Active infection or ulcer at the lumbar injection site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substance P-Saporin | Drug | SP-SAP ARM |
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.
1 secondary outcome
Safety Tolerability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Individual participant dataSharing planned: No
Related trials for Terminally Ill
Not yet recruitingObservational study
Palliative Care and The Terminally Ill Adults (End of Life) Bill
Assisted Dying, Palliative Care
Not yet recruitingObservational study
Mapping Financial Support for the Terminally Ill
People with Terminal Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Frankel, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Substance P-Saporin in people with Terminally Ill and Histologically-confirmed Advanced Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Evaluation Criteria (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.