Intractable Pain, Neoplasms
Conditions
Keywords
pain, cancer, malignancy, intractable, gene therapy, enkephalin, opioid
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALNP2
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.
BIOLOGICALPlacebo
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.
Sponsors
Paragon Biomedical
invivodata, Inc.
Diamyd Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured by the Numerical Rating Scale (NRS) | Days -5 to -1 predosing and days 3 to 14 postdosing | • Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Pain Medication Usage Morphine Equivalent Units (MEU) | Days -5 to -1 predosing and 3 to 14 postdosing | •Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts |
| Quality of Life ECOG | Baseline and Week 1, 2 and 4 | •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. |
| Quality of Life SF-12 | Baseline and Week 1, 2 and 4 | •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. |
| Pain SF-MPQ | Baseline and Week 1, 2 and 4 | •Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts |
Countries
United States
Outcome results
None listed