NCT00804076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

December 3, 2008

Last Update Submit

February 18, 2014

Conditions

Cancer Pain

Keywords

gene therapyreplication defective HSV vectorpainenkephalinintradermal

Outcome Measures

Primary Outcomes (1)

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

    4 Months

Secondary Outcomes (1)

  • Evaluate changes in cancer-related pain

    4 Months

Study Arms (1)

NP2

EXPERIMENTAL

Intradermal injection

Biological: NP2

Interventions

NP2BIOLOGICAL

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

NP2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Advanced Pharma CR

Miami, Florida, 33175, United States

Location

Louisiana Research Associates

New Orleans, Louisiana, 70114, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 49109, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Pain Research of Oregon, LLC

Eugene, Oregon, 97401, United States

Location

Related Publications (4)

  • 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.

    PMID: 11319622BACKGROUND

  • 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.

    PMID: 12620604BACKGROUND

  • 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.

    PMID: 12402268BACKGROUND

  • 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.

    PMID: 18841093BACKGROUND

MeSH Terms

Conditions

Cancer PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David J Fink, MD

    University of Michigan Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 8, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2010

Study Completion

July 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

US(5)