Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.
Biological: adenovirus-mediated human interleukin-12
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver|
|Study Start Date:||October 2005|
- Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.
- Determine tumor responses produced by this regimen.
- Determine immune responses induced by this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive adenovirus-mediated human interleukin-12 via percutaneous intratumoral needle puncture under ultrasound guidance on day 1.
Cohorts of 3-6 patients receive escalating doses of adenovirus-mediated human interleukin-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301106
|United States, New York|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Study Chair:||Max W. Sung, MD||Icahn School of Medicine at Mount Sinai|