Gene Transfer for Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Diamyd Inc
ClinicalTrials.gov Identifier:
NCT00804076
First received: December 3, 2008
Last updated: February 18, 2014
Last verified: February 2014

December 3, 2008
February 18, 2014
February 2008
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00804076 on ClinicalTrials.gov Archive Site
Evaluate changes in cancer-related pain [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gene Transfer for Cancer Pain
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer Pain
Biological: NP2
Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.
Experimental: NP2
Intradermal injection
Intervention: Biological: NP2

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2013
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00804076
NP2/P1/07/1
Yes
Diamyd Inc
Diamyd Inc
Not Provided
Principal Investigator: David J Fink, MD University of Michigan Department of Neurology
Diamyd Inc
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP