NP2 Enkephalin For Treatment of Intractable Cancer Pain - Full Text View

Purpose

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.

Condition	Intervention	Phase
Intractable Pain Neoplasms	Biological: NP2 Biological: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Diamyd Inc:

Primary Outcome Measures:

Pain Measured by the Numerical Rating Scale (NRS) [ Time Frame: Days -5 to -1 predosing and days 3 to 14 postdosing ] [ Designated as safety issue: No ]
• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.

Secondary Outcome Measures:

Opioid Pain Medication Usage Morphine Equivalent Units (MEU) [ Time Frame: Days -5 to -1 predosing and 3 to 14 postdosing ] [ Designated as safety issue: No ]
•Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts
Quality of Life ECOG [ Time Frame: Baseline and Week 1, 2 and 4 ] [ Designated as safety issue: No ]
•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 [ Time Frame: Baseline and Week 1, 2 and 4 ] [ Designated as safety issue: No ]
•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 [ Time Frame: Baseline and Week 1, 2 and 4 ] [ Designated as safety issue: No ]
•Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts

Estimated Enrollment:	32
Study Start Date:	January 2011
Estimated Study Completion Date:	November 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active NP2 Single intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.	Biological: NP2 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.
Placebo Comparator: Placebo Single intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.	Biological: Placebo 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291901

Locations

United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, California
Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States, 92879
Cancer Care Associates
Fresno, California, United States, 93720
TriWest Research Associates
La Mesa, California, United States, 91942
White Memorial Medical Center
Los Angeles, California, United States, 90033
Hematology Oncology Associates
Oakland, California, United States, 94609
United States, Florida
Advanced Pharma CR
Miami, Florida, United States, 33175
United States, Georgia
Better Health Clinical Research Inc
Newnan, Georgia, United States, 30265
United States, Illinois
Christie Clinic
Champaign, Illinois, United States, 61820
United States, Indiana
Global Scientific Innovations
Evansville, Indiana, United States, 47714
United States, Montana
Montana Cancer Institute Foundation
Missoula, Montana, United States, 59802
United States, North Carolina
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Signal Point Clinical research Center
Middletown, Ohio, United States, 45042
United States, Oregon
Pain Research of Oregon
Eugene, Oregon, United States, 97401
United States, Rhode Island
Hematology Oncology Associatesof Rhode Island
Cranston, Rhode Island, United States, 02920
United States, Texas
Medical Therapy and Research
San Antonio, Texas, United States, 78217
United States, Washington
Medical Oncology Associates
Spokane, Washington, United States, 99208

Sponsors and Collaborators

Diamyd Inc

Paragon Biomedical

invivodata, Inc.

Investigators

Study Director:	Darren Wolfe, Ph.D.	Diamyd Inc
Principal Investigator:	David Fink, M.D.	University of Michigan

More Information

No publications provided

Responsible Party:	Diamyd Inc
ClinicalTrials.gov Identifier:	NCT01291901 History of Changes
Other Study ID Numbers:	NP2/P2/10/2
Study First Received:	February 4, 2011
Last Updated:	October 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Diamyd Inc:

pain
cancer
malignancy
intractable

gene therapy
enkephalin
opioid

Additional relevant MeSH terms:

Neoplasms
Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Enkephalins
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013