At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 10 enrolled
Drug / intervention
NP2biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating NP2 for Cancer Pain. Completed, enrolled 10 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer Pain
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedDec 2008
Primary CompletionNov 2010
Study CompletionJul 2013
TodayJul 2026
First PostedDec 8, 2008
Enrollment StartFeb 1, 2008
Primary CompletionNov 1, 2010
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.6 years ago
Interventions
NP2biological
Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.