A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Contact: | Arthur Frankel, MD |
| Email: | arthur.frankel@utsouthwestern.edu |
| Phone: | 214-648-1579 |
SP-SAP is an experimental drug used to treat chronic pain associated with cancer in patients
that are no longer responsive to other pain medications. SP-SAP works by targeting nerves
in the spinal cord that are responsible for transmitting pain. When SP-SAP finds these
nerves, the nerves are destroyed and the pain is eliminated. Subjects will receive a single
injection of the drug into the spinal column. Subjects will then return for regular
appointments for evaluation up to 6 months.
that are no longer responsive to other pain medications. SP-SAP works by targeting nerves
in the spinal cord that are responsible for transmitting pain. When SP-SAP finds these
nerves, the nerves are destroyed and the pain is eliminated. Subjects will receive a single
injection of the drug into the spinal column. Subjects will then return for regular
appointments for evaluation up to 6 months.
Inclusion Criteria:
- Age 18 or older
- Signed informed consent
- Terminally ill (less than or equal to 6 months) cancer patients with intractable
chronic pain
- Minimal expected survival time of one month
- Able to verbally report pain
- Able to perform motor/sensory tests
- Able to undergo a 4hr intrathecal catheter placement
- Other therapeutic and palliative options have been exhausted
Exclusion Criteria:
- 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
- Active infection or ulcer at the lumbar injection site
- Inability to receive lumbar intrathecal injection because of other factors
- 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., central nervous system or coagulopathy)
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