Clinical trial NCT01291901: NP2 Enkephalin For Treatment of Intractable Cancer Pain
Official title: A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intractable Pain
Neoplasms
Keywords: pain
cancer
malignancy
intractable
gene therapy
enkephalin
opioid
Lead sponsor: Diamyd Inc
Sponsor class: INDUSTRY
Collaborators: name: Paragon Biomedical
name: invivodata, Inc.
First posted: 2011-02-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain Measured by the Numerical Rating Scale (NRS)
timeFrame: Days -5 to -1 predosing and days 3 to 14 postdosing
Secondary outcomes:
measure: Opioid Pain Medication Usage Morphine Equivalent Units (MEU)
timeFrame: Days -5 to -1 predosing and 3 to 14 postdosing
measure: Quality of Life ECOG
timeFrame: Baseline and Week 1, 2 and 4
measure: Quality of Life SF-12
timeFrame: Baseline and Week 1, 2 and 4
measure: Pain SF-MPQ
timeFrame: Baseline and Week 1, 2 and 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group, Inc.
state: California
city: Fresno
country: United States
facility: Cancer Care Associates
state: California
city: La Mesa
country: United States
facility: TriWest Research Associates
state: California
city: Los Angeles
country: United States
facility: White Memorial Medical Center
state: California
city: Oakland
country: United States
facility: Hematology Oncology Associates
state: California
city: Miami
country: United States
facility: Advanced Pharma CR
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Research Inc
state: Georgia
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Evansville
country: United States
facility: Global Scientific Innovations
state: Indiana
city: Missoula
country: United States
facility: Montana Cancer Institute Foundation
state: Montana
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Middletown
country: United States
facility: Signal Point Clinical research Center
state: Ohio
city: Eugene
country: United States
facility: Pain Research of Oregon
state: Oregon
city: Cranston
country: United States
facility: Hematology Oncology Associatesof Rhode Island
state: Rhode Island
city: San Antonio
country: United States
facility: Medical Therapy and Research
state: Texas
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
Study officials:
affiliation: Diamyd Inc
name: Darren Wolfe, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: David Fink, M.D.
role: PRINCIPAL_INVESTIGATOR
References: