Gene Therapy in Treating Women With Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
recurrent breast cancer, stage IV breast cancer
Study Type
Interventional
Study Phase
Phase 1
Study Design
Primary Purpose: Treatment
Intervention
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
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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:

- 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

PRIOR CONCURRENT THERAPY:

- 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
Location
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
Sponsors
Icahn School of Medicine at Mount Sinai
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page