Clinical trial · Interventional
Gene Transfer for Cancer Pain
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
NCT00804076CI-TRIAL-00013804completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NP2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NP2
- description
- Intradermal injection
- interventionNames
- Biological: NP2
Primary outcomes (1)
- measure
- Safety measured by vital signs, physical exam findings, clinical laboratory analyses and treatment related Adverse Events (AE).
- timeFrame
- 4 Months
Secondary outcomes (1)
- measure
- Evaluate changes in cancer-related pain
- timeFrame
- 4 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with intractable pain from malignant disease with a 5 year projected survival of less than 25%. 2. Female patients of childbearing potential who have a negative pregnancy test and using birth control. 3. 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. 4. Patients who have not had surgical stabilization/resection within 4 weeks of Screening and have no plans for additional surgical procedures. 5. Patients with adequate bone marrow function, IgG levels greater than 565 mg% and CD4 count greater than 500. . Exclusion Criteria: 1. Patients with serious uncontrolled medical conditions other than malignancy. 2. Patients with severe liver or renal impairment 3. Patients currently or previously with positive serology for HIV, Hepatitis B or Hepatitis C. 4. Patients with a hemoglobin \<9 gm% or uncontrolled coagulopathy or bleeding diathesis. 5. Patients with a clinical diagnosis of any active herpes infection within the past 6 months. 6. Patients who have been vaccinated to prevent HSV infection or a history of shingles or the presence of active shingles.
References
Publications (4)
- BACKGROUNDGoss 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 11319622
- BACKGROUNDHao 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 12620604
- BACKGROUNDGoss 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 12402268
- BACKGROUNDGlorioso 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 18841093