Breast Cancer Clinical Trial
Official title:
Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body
build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in
treating women 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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