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

NCT02036281 | Completed Phase 1 DMC

• 1 other identifier: STU 102013-010
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Terminally Ill; Histologically-confirmed Advanced Cancer; Pain, Intractable

Keywords

Terminally ill , histologically-confirmed advanced cancer; Pain unrelieved by opioids

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Safety Tolerability

  6 months

Study Arms (1)

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.

Drug: Substance P-Saporin

Interventions

Substance P-Saporin DRUG

SP-SAP ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of California, San Diego Mores Cancer Center

La Jolla, California, 92093-0698, United States

Location

UT Southwestern Medical Center Simmons Comprehensive Cancer Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pain, Intractable

Interventions

substance P-saporin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur Frankel, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 15, 2014
• Study Start: January 1, 2014
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)