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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 3, 2008

Last Updated Date

February 18, 2014

Start Date ^ICMJE

February 2008

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00804076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gene Transfer for Cancer Pain

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer Pain

Intervention ^ICMJE

Biological: NP2

Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.

Study Arm (s)

Experimental: NP2

Intradermal injection

Intervention: Biological: NP2

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2013

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00804076

Other Study ID Numbers ^ICMJE

NP2/P1/07/1

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Diamyd Inc

Study Sponsor ^ICMJE

Diamyd Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David J Fink, MD

University of Michigan Department of Neurology

Information Provided By

Diamyd Inc

Verification Date

February 2014

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

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