Spots Global Cancer Trial Database for Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
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Trial Identification
Brief Title: Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
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 ID: NCT00301106
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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). OBJECTIVES: * 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Mount Sinai Medical Center, New York, New York, United States
Contact Details
Name: Max W. Sung, MD
Affiliation: Icahn School of Medicine at Mount Sinai
Role: STUDY_CHAIR
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