NP2 Enkephalin For Treatment of Intractable Cancer Pain

Phase 2CompletedNCT01291901

Diamyd Inc33 enrolled

Overview

The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.

Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Intractable Pain Neoplasms

Interventions

NP2BIOLOGICAL

NP2 is a replication defective HSV-1 based gene transfer vector engineered to express human preproenkephalin. The drug will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.

PlaceboBIOLOGICAL

The placebo (vehicle) will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Main Inclusion Criteria: * Histologically confirmed malignant disease. * Intractable pain related to malignancy. * Females must be postmenopausal or practicing birth control. * Able to provide appropriate written consent. Main Exclusion Criteria: * Positive pregnancy test prior to receiving study treatment. * Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes). * Evidence of active Hepatitis B, Hepatitis C, or HIV infection. * Evidence of viral, bacterial, or fungal infection in the planned treatment area.

Locations (18)

HOPE Research Institute

Phoenix, Arizona, United States

Arizona Clinical Research Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Pain Measured by the Numerical Rating Scale (NRS)

• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.

Time frame: Days -5 to -1 predosing and days 3 to 14 postdosing

Secondary Outcomes

Opioid Pain Medication Usage Morphine Equivalent Units (MEU)

•Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts

Time frame: Days -5 to -1 predosing and 3 to 14 postdosing

Quality of Life ECOG

•Quality of Life measured by Eastern Cooperative Oncology Group Performance Status (ECOG) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.

Time frame: Baseline and Week 1, 2 and 4

Quality of Life SF-12

•Quality of Life measured by the 12-Item Short Form Health Survey (SF-12v2) at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.

Time frame: Baseline and Week 1, 2 and 4

Pain SF-MPQ

•Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts

Time frame: Baseline and Week 1, 2 and 4

Data from ClinicalTrials.gov

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