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

• Status: Completed
• Trial end date: 2016-09-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Neurokinin A; Saporin; Substance P

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Signed informed consent

3. 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.

4. Minimal expected survival time of one month

5. ECOG Performance status of 0 - 3

6. Able to verbally report pain

7. Able to indicate pain on a VAS

8. Able to perform motor/sensory tests

9. Able to undergo a 4-h intrathecal catheter placement

10. Other therapeutic and palliative options have been exhausted

Exclusion Criteria:

1. Concurrent therapy with an investigational agent

2. Concurrent radiation or chemotherapy

3. 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.

4. Diagnosis of intractable chronic pain of the chest, head, neck or upper extremities.

5. Active infection or ulcer at the lumbar injection site

6. Inability to receive lumbar intrathecal injection because of other factors

7. Diagnosis of meningitis or encephalitis

8. 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

9. Comorbidities at particular risk (i.e., CNS, CNS metastases, hydrocephalus or coagulopathy)