Gene Therapy in Treating Women With Metastatic Breast Cancer

Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer

NCT00849459•Max Sung

View on ClinicalTrials.gov

Summary

RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.

Detailed Description

OBJECTIVES: * Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer. * Determine the tumor response in patients treated with this regimen. * Determine the immune response in patients treated with this regimen. OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance. Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS. After completion of study therapy, patients are followed periodically.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
•* Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection
•* Solitary or multiple tumors
•* Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan
•* Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination
•* Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination
•* Malignant disease in other organs (in addition to skin or chest wall metastases) allowed
•Hormone receptor status not specified
•PATIENT CHARACTERISTICS:
+22 more criteria

Locations (1)

Icahn Medical Center at Mount Sinai

New York, New York, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

January 11, 2017

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

adenovirus-mediated human interleukin-12

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Gene Therapy in Treating Women With Metastatic Breast Cancer

Inclusion Criteria

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