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Sponsored by: |
Mount Sinai School of Medicine |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301106 |
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 | Intervention | Phase |
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Breast Cancer Metastatic Cancer |
Biological: adenovirus-mediated human interleukin-12 |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 36 |
Study Start Date: | October 2005 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed* breast adenocarcinoma metastatic to the liver
Solitary or multiple hepatic metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry
United States, New York | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 |
Study Chair: | Max W. Sung, MD | Mount Sinai School of Medicine |
Study ID Numbers: | CDR0000456626, MTS-GCO-97-779, MTS-9911-358, MTS-A-8200 |
Study First Received: | March 8, 2006 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00301106 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IV breast cancer liver metastases |
Interleukin-12 Immunologic Factors Skin Diseases Adjuvants, Immunologic |
Neoplasm Metastasis Breast Neoplasms Angiogenesis Inhibitors Breast Diseases |
Interleukin-12 Skin Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Breast Neoplasms Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Growth Inhibitors Angiogenesis Modulating Agents Breast Diseases |