Gene Therapy in Treating Women With Metastatic Breast Cancer
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
recurrent breast cancer, stage IV breast cancer
Study Type
Study Phase
Phase 1
Study Design
Primary Purpose: Treatment
Name: adenovirus-mediated human interleukin-12 Type: Biological
Name: enzyme-linked immunosorbent assay Type: Other
Name: fluorescence activated cell sorting Type: Other
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
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

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female

- 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


- Menopausal status not specified

- Karnofsky performance status 70-100%

- Life expectancy ≥ 16 weeks

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 mg/dL

- PT normal

- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min

- Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)

- Serum transaminases ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)

- No active infection or concurrent serious medical illness

- No HIV positivity

- No other malignancy within the past 5 years except for the following:

- Inactive nonmelanoma skin cancer

- In situ carcinoma of the cervix

- Grade 1 papillary bladder cancer


- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment
Mount Sinai School of Medicine
New York, New York, United States
Status: Recruiting
Contact: Clinical Trials Office - Mount Sinai School of Medicine - 212-659-8050
Start Date
August 2008
Icahn School of Medicine at Mount Sinai
National Cancer Institute (NCI)
Record processing date processed this data on July 28, 2015 page