Gene Transfer for Cancer Pain
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ClinicalTrials.gov Identifier: NCT00804076 |
Recruitment Status
:
Completed
First Posted
: December 8, 2008
Last Update Posted
: February 19, 2014
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Sponsor:
Diamyd Inc
Information provided by (Responsible Party):
Diamyd Inc
Tracking Information | ||||
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First Submitted Date ICMJE | December 3, 2008 | |||
First Posted Date ICMJE | December 8, 2008 | |||
Last Update Posted Date | February 19, 2014 | |||
Study Start Date ICMJE | February 2008 | |||
Actual 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 ] | |||
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 ] | |||
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 | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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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. |
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Study Arms | Experimental: NP2
Intradermal injection
Intervention: Biological: NP2 |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE |
12 | |||
Actual Study Completion Date | July 2013 | |||
Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
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 | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Diamyd Inc | |||
Study Sponsor ICMJE | Diamyd Inc | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Diamyd Inc | |||
Verification Date | February 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |