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A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain


Phase 1
18 Years
N/A
Not Enrolling
Both
Intractable Pain in Terminal Cancer Patients.

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Trial Information

A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain


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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events using the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4 as a measure of safety and tolerability in subjects with chronic pain refractory to opioid therapy.

Outcome Time Frame:

Patients will be followed weekly for 8 weeks, then monthly for up to 6 months.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

SP-SAP

NCT ID:

NCT01875432

Start Date:

Completion Date:

Related Keywords:

  • Intractable Pain in Terminal Cancer Patients.
  • Pain, Intractable
  • Neoplasms

Name

Location

University of Texas Southwestern Medical CenterDallas, Texas