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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer Pain

Thank you

Trial Information

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


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.


Inclusion Criteria:



1. Patients with intractable pain from malignant disease with a 5 year projected
survival of less than 25%.

2. Female patients of childbearing potential who have a negative pregnancy test and
using birth control.

3. 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.

4. Patients who have not had surgical stabilization/resection within 4 weeks of
Screening and have no plans for additional surgical procedures.

5. Patients with adequate bone marrow function, IgG levels greater than 565 mg% and CD4
count greater than 500. .

Exclusion Criteria:

1. Patients with serious uncontrolled medical conditions other than malignancy.

2. Patients with severe liver or renal impairment

3. Patients currently or previously with positive serology for HIV, Hepatitis B or
Hepatitis C.

4. Patients with a hemoglobin <9 gm% or uncontrolled coagulopathy or bleeding diathesis.

5. Patients with a clinical diagnosis of any active herpes infection within the past 6
months.

6. Patients who have been vaccinated to prevent HSV infection or a history of shingles
or the presence of active shingles.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).

Outcome Time Frame:

4 Months

Safety Issue:

Yes

Principal Investigator

David J Fink, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Department of Neurology

Authority:

United States: Food and Drug Administration

Study ID:

NP2/P1/07/1

NCT ID:

NCT00804076

Start Date:

February 2008

Completion Date:

September 2013

Related Keywords:

  • Cancer Pain
  • gene therapy
  • replication defective HSV vector
  • pain
  • enkephalin
  • intradermal

Name

Location

University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Center For Clinical ResearchWinston Salem, North Carolina  27103
Louisiana Research AssociatesNew Orleans, Louisiana  70114
Advanced Pharma CRMiami, Florida  33175
Pain Research of Oregon, LLCEugene, Oregon  97401