Gene Transfer for Cancer Pain
Completed · Phase 1
Conditions studied: Cancer Pain
In brief
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.
Key facts
- Study ID
- NCT00804076
- Run by
- Diamyd Inc
- People needed
- 10
- Starts
- 2008-02-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2014-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Advanced Pharma CR — Miami, Florida, United States
- Louisiana Research Associates — New Orleans, Louisiana, United States
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- Center for Clinical Research — Winston-Salem, North Carolina, United States
- Pain Research of Oregon, LLC — Eugene, Oregon, United States
Full record on ClinicalTrials.gov
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