Cancer PainPhase 1NCT00804076
Gene Transfer for Cancer Pain
A Phase 1 study testing NP2 in people with Cancer Pain, run by Diamyd Inc at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- NP2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2008to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. .
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 49109
Pain Research of Oregon, LLC
Eugene, Oregon, 97401
Advanced Pharma CR
Miami, Florida, 33175
Louisiana Research Associates
New Orleans, Louisiana, 70114
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Cancer Pain
- Being tested
- NP2
- Keywords
- gene therapy, replication defective HSV vector, pain, enkephalin, intradermal
- Medical subject headings
- Cancer Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP2Biological
Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.
| Study group | Role | What they receive |
|---|---|---|
| NP2 | Experimental | Intradermal injection Receives: Biological: NP2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).
Measured: 4 Months
Secondary outcomes (1)
Evaluate changes in cancer-related pain
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2010
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamyd Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Fink, MD, Principal investigator, University of Michigan Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804076
- Sponsor's protocol ID
- NP2/P1/07/1
- Status last verified
- Feb 2014
- First submitted
- 3 Dec 2008
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11319622Hao 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.
PubMed 12620604Goss 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.
PubMed 12402268Glorioso 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.
PubMed 18841093
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00804076
- Acronym / sponsor ID
- NP2/P1/07/1
- Conditions
- Cancer Pain
- Keywords
- gene therapy, replication defective HSV vector, pain, enkephalin, intradermal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Diamyd IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NP2 | Experimental | Biological: NP2Intradermal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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. .
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP2Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain. | Biological | NP2 |
Primary outcome
Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).
Time frame: 4 Months
1 secondary outcome
Evaluate changes in cancer-related pain
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Background: PubMed 11319622Goss 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.
- Background: PubMed 12620604Hao 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.
- Background: PubMed 12402268Goss 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.
- Background: PubMed 18841093Glorioso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Fink, MD principal investigator
University of Michigan Department of Neurology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NP2 in people with Cancer Pain, run by Diamyd Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE). (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804076, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.