Gene Therapy in Treating Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00849459|
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : January 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: adenovirus-mediated human interleukin-12||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|