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Gene Transfer for Cancer Pain

Primary Purpose

Cancer Pain

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NP2

About this trial

This is an interventional treatment trial for Cancer Pain focused on measuring gene therapy, replication defective HSV vector, pain, enkephalin, intradermal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Advanced Pharma CR
Louisiana Research Associates
University of Michigan Medical Center
Center for Clinical Research
Pain Research of Oregon, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NP2

Arm Description

Intradermal injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate changes in cancer-related pain

Full Information

NCT ID

NCT00804076

First Posted

December 3, 2008

Last Updated

February 18, 2014

Sponsor

Diamyd Inc

1. Study Identification

Unique Protocol Identification Number

NCT00804076

Brief Title

Gene Transfer for Cancer Pain

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diamyd Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Pain

Keywords

gene therapy, replication defective HSV vector, pain, enkephalin, intradermal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NP2

Arm Type

Experimental

Arm Description

Intradermal injection

Intervention Type

Biological

Intervention Name(s)

NP2

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4 Months

Secondary Outcome Measure Information:

Title

Evaluate changes in cancer-related pain

Time Frame

4 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David J Fink, MD

Organizational Affiliation

University of Michigan Department of Neurology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Advanced Pharma CR

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Louisiana Research Associates

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70114

Country

United States

Facility Name

University of Michigan Medical Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

49109

Country

United States

Facility Name

Center for Clinical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Pain Research of Oregon, LLC

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11319622

Citation

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. doi: 10.1038/sj.gt.3301430.

Results Reference

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PubMed Identifier

12620604

Citation

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. doi: 10.1016/s0304-3959(02)00346-9.

Results Reference

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PubMed Identifier

12402268

Citation

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. doi: 10.1002/ana.10343.

Results Reference

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PubMed Identifier

18841093

Citation

Glorioso JC, Fink DJ. Herpes vector-mediated gene transfer in the treatment of chronic pain. Mol Ther. 2009 Jan;17(1):13-8. doi: 10.1038/mt.2008.213. Epub 2008 Oct 7.

Results Reference

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Gene Transfer for Cancer Pain

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