Gene Transfer for Cancer Pain - Full Text View

Purpose

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
Cancer Pain	Biological: NP2	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Diamyd Inc:

Primary Outcome Measures:

Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE). [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate changes in cancer-related pain [ Time Frame: 4 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2013
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NP2 Intradermal injection	Biological: NP2 Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.

Detailed Description:

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.

Eligibility

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

Criteria

Inclusion Criteria:

Patients with intractable pain from malignant disease with a 5 year projected survival of less than 25%.
Female patients of childbearing potential who have a negative pregnancy test and using birth control.
Patients who have not received recent treatment with a radiation, chemotherapeutic or immunotherapeutic agent and are not expected to undergo such treatment 28 days after injection of NP2.
Patients who have not had surgical stabilization/resection within 4 weeks of Screening and have no plans for additional surgical procedures.
Patients with adequate bone marrow function, IgG levels greater than 565 mg% and CD4 count greater than 500. .

Exclusion Criteria:

Patients with serious uncontrolled medical conditions other than malignancy.
Patients with severe liver or renal impairment
Patients currently or previously with positive serology for HIV, Hepatitis B or Hepatitis C.
Patients with a hemoglobin <9 gm% or uncontrolled coagulopathy or bleeding diathesis.
Patients with a clinical diagnosis of any active herpes infection within the past 6 months.
Patients who have been vaccinated to prevent HSV infection or a history of shingles or the presence of active shingles.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804076

Locations

United States, Florida
Advanced Pharma CR
Miami, Florida, United States, 33175
United States, Louisiana
Louisiana Research Associates
New Orleans, Louisiana, United States, 70114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 49109
United States, North Carolina
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Pain Research of Oregon, LLC
Eugene, Oregon, United States, 97401

Sponsors and Collaborators

Diamyd Inc

Investigators

Principal Investigator:

David J Fink, MD

University of Michigan Department of Neurology

More Information

Publications:

Goss JR, Mata M, Goins WF, Wu HH, Glorioso JC, Fink DJ. Antinociceptive effect of a genomic herpes simplex virus-based vector expressing human proenkephalin in rat dorsal root ganglion. Gene Ther. 2001 Apr;8(7):551-6.

Hao S, Mata M, Goins W, Glorioso JC, Fink DJ. Transgene-mediated enkephalin release enhances the effect of morphine and evades tolerance to produce a sustained antiallodynic effect in neuropathic pain. Pain. 2003 Mar;102(1-2):135-42.

Goss JR, Harley CF, Mata M, O'Malley ME, Goins WF, Hu X, Glorioso JC, Fink DJ. Herpes vector-mediated expression of proenkephalin reduces bone cancer pain. Ann Neurol. 2002 Nov;52(5):662-5.

Glorioso JC, Fink DJ. Herpes Vector-mediated Gene Transfer in the Treatment of Chronic Pain. Mol Ther. 2008 Oct 7; [Epub ahead of print]

Responsible Party:	Diamyd Inc
ClinicalTrials.gov Identifier:	NCT00804076 History of Changes
Other Study ID Numbers:	NP2/P1/07/1
Study First Received:	December 3, 2008
Last Updated:	October 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Diamyd Inc:

gene therapy
replication defective HSV vector
pain
enkephalin
intradermal

ClinicalTrials.gov processed this record on May 23, 2013