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.
|Breast Cancer Metastatic Cancer||Biological: adenovirus-mediated human interleukin-12||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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|
- Toxicity [ Time Frame: up to 15 days ]Serial monitoring of tumor necrosis factor alpha (TNFα) levels
- Tumor Response [ Time Frame: up to 2 months ]Sequential assessment of tumor on CT or MRI
- IL12 level Immune response [ Time Frame: up to 2 months ]Serum IL12 level
- IFNγ levels Immune response [ Time Frame: up to 2 months ]IFNγ levels
- Immune response [ Time Frame: up to 2 months ]Serum antibodies (titer) to adenovirus.
|Study Start Date:||October 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (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.
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12).
- 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.
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|