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Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver

2014-08-27 03:45:44 | BioPortfolio

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.

Description

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.

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.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

adenovirus-mediated human interleukin-12

Location

Mount Sinai Medical Center
New York
New York
United States
10029

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:44-0400

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Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Tumors or cancer of the human BREAST.

Tumors or cancer found specifically in one human BREAST, but not in both.

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A secretoglobin that is produced by the MAMMARY GLAND of HUMANS and may be involved in the binding of ANDROGENS and other STEROIDS. The expression of this protein in normal breast epithelium and in human breast cancer has made it an important histological marker.

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