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

What Was Tested

The trial (phase 1) is built around Substance P.

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.

It had 1 arm (groups): SP-SAP ARM (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Follow-Up will occur weekly for 8 weeks and then monthly for 4 months as needed.

This information may be collected via patient diary, office visit or telephone interview.

Who Took Part

Enrollment: 23 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Signed informed consent. Minimal expected survival time of one month. ECOG Performance status of 0 - 3. Able to verbally report pain.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: concurrent therapy with an investigational agent; concurrent radiation or chemotherapy; diagnosis of intractable chronic pain of the chest, head, neck or upper extremities.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Substance P was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-01 with completion listed for 2016-09-28.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Response Evaluation Criteria (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example Safety Tolerability.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Substance P in 23 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Substance P compound page, all human trials.