Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
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|ClinicalTrials.gov Identifier: NCT00301106|
Recruitment Status : Terminated (protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459)
First Posted : March 10, 2006
Last Update Posted : February 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Cancer||Biological: adenovirus-mediated human interleukin-12||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 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 Patients With Metastatic Breast Cancer to the Liver|
|Study Start Date :||October 2005|
|Primary Completion Date :||August 2008|
|Study Completion Date :||August 2008|
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.
- 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.
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): 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|