NP2 Enkephalin For Treatment of Intractable Cancer Pain
NCT ID: NCT01291901
Last Updated: 2014-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2011-01-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
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.
Interventions
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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
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 Criteria
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Inclusion Criteria
* Intractable pain related to malignancy.
* Females must be postmenopausal or practicing birth control.
* Able to provide appropriate written consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Paragon Biomedical
INDUSTRY
invivodata, Inc.
INDUSTRY
Diamyd Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Darren Wolfe, Ph.D.
Role: STUDY_DIRECTOR
Diamyd Inc
David Fink, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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HOPE Research Institute
Phoenix, Arizona, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States
Cancer Care Associates
Fresno, California, United States
TriWest Research Associates
La Mesa, California, United States
White Memorial Medical Center
Los Angeles, California, United States
Hematology Oncology Associates
Oakland, California, United States
Advanced Pharma CR
Miami, Florida, United States
Better Health Clinical Research Inc
Newnan, Georgia, United States
Christie Clinic
Champaign, Illinois, United States
Global Scientific Innovations
Evansville, Indiana, United States
Montana Cancer Institute Foundation
Missoula, Montana, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Signal Point Clinical research Center
Middletown, Ohio, United States
Pain Research of Oregon
Eugene, Oregon, United States
Hematology Oncology Associatesof Rhode Island
Cranston, Rhode Island, United States
Medical Therapy and Research
San Antonio, Texas, United States
Medical Oncology Associates
Spokane, Washington, United States
Countries
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Other Identifiers
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NP2/P2/10/2
Identifier Type: -
Identifier Source: org_study_id
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