Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
OBJECTIVES:
- Determine the toxicity and maximum tolerated dose of intratumoral injection of
adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.
- Determine the tumor response in patients treated with this regimen.
- Determine the immune response in patients treated with this regimen.
OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12
intratumorally via percutaneous needle placement under ultrasound guidance.
Blood and tumor tissue samples are collected periodically for immunological laboratory
studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of
immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.
After completion of study therapy, patients are followed periodically.
Interventional
Primary Purpose: Treatment
Maximum tolerated dose
Yes
Max W. Sung, MD
Principal Investigator
Mount Sinai School of Medicine
Unspecified
CDR0000629819
NCT00849459
August 2008
Name | Location |
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Mount Sinai School of Medicine | New York, New York 10029 |