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

Phase 1
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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


- 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.

Inclusion Criteria


- 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

- 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)

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Max W. Sung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine



Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Mount Sinai School of MedicineNew York, New York  10029