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Sponsored by: |
Diamyd Inc |
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Information provided by: | Diamyd Inc |
ClinicalTrials.gov Identifier: | NCT00804076 |
The primary purpose of this study is to examine the safety of NP2 (a nonreplicating HSV-based vector expressing enkephalin) in patients with cancer pain.
The secondary purpose is to evaluate efficacy.
Condition | Intervention | Phase |
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Cancer Pain |
Biological: NP2 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Gene Transfer for Intractable Pain: A Phase I Clinical Trial to Determine the Maximum Tolerable Dose of a Replication-Defective Herpes Simplex Virus Type I (HSV-1) Vector Expressing Human Preproenkephalin (NP2) in Patients With Malignancies |
Estimated Enrollment: | 12 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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NP2: Experimental
Intradermal injection
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Biological: NP2
Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.
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Therapeutic HSV-based vectors deliver genes from skin inoculation to sensory neurons to interrupt pain signaling at the spinal level. Side effects may be limited by the focal distribution of vector delivery and preproenkephalin expression. Preproenkephalin is a natural human gene that produces peptides that bind to opioid receptors in the body. The therapeutic being evaluated, NP2, is a replication defective herpes simplex type 1 virus (HSV-1) modified to express the human preproenkephalin gene that has demonstrated efficacy in numerous model of pain, including pain caused by cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David J Fink, MD | 734-936-9070 | djfink@med.umich.edu |
Contact: Susan Urba, MD | 734 657-5093 | surba@med.umich.edu |
United States, Michigan | |
University of Michigan Medical Center | Recruiting |
Ann Arbor, Michigan, United States, 49109 | |
Contact: David J Fink, MD 734-936-9070 djfink@med.umich.edu | |
Principal Investigator: David J Fink, MD | |
Sub-Investigator: Susan Urba, MD | |
Sub-Investigator: Frank Worden, MD |
Principal Investigator: | David J Fink, MD | University of Michigan Department of Neurology |
Responsible Party: | University of Michigan Medical Center ( David Fink ) |
Study ID Numbers: | NP2/P1/07/1 |
Study First Received: | December 3, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804076 History of Changes |
Health Authority: | United States: Food and Drug Administration |
gene therapy replication defective HSV vector pain enkephalin intradermal |
Virus Diseases Pain, Intractable Herpes Simplex Pain Enkephalins |