Status:
COMPLETED
Gene Transfer for Cancer Pain
Lead Sponsor:
Diamyd Inc
Conditions:
Cancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 de...
Eligibility Criteria
Inclusion
- 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. .
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00804076
Start Date
February 1 2008
End Date
July 1 2013
Last Update
February 19 2014
Active Locations (5)
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1
Advanced Pharma CR
Miami, Florida, United States, 33175
2
Louisiana Research Associates
New Orleans, Louisiana, United States, 70114
3
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 49109
4
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103