Gene Therapy in Treating Women 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.
|Breast Cancer||Biological: adenovirus-mediated human interleukin-12||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer|
- Maximum tolerated dose [ Time Frame: up to 1 month ]Serum antibodies (titer) to adenovirus
- Toxicity and safety [ Time Frame: up to 2 months ]adverse events as assessed by NCI CTCAE v3.0
- Tumor response progression) [ Time Frame: up to 2 months ]Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)
- Immune response [ Time Frame: up to 2 months ]Serum IL12, and IFNγ levels. Serum antibodies (titer) to adenovirus.
|Study Start Date:||August 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: adenovirus-mediated human interleukin-12
starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient.
Biological: adenovirus-mediated human interleukin-12
The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/
1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849459
|United States, New York|
|Icahn Medical Center at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Max W. Sung, MD||Icahn Medical Center at Mount Sinai|