Clinical trial NCT00849459: Gene Therapy in Treating Women With Metastatic Breast Cancer
Official title: Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: recurrent breast cancer
stage IV breast cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2009-02-23
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: up to 1 month
measure: Toxicity and safety
timeFrame: up to 2 months
Secondary outcomes:
measure: Tumor response progression)
timeFrame: up to 2 months
measure: Immune response
timeFrame: up to 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn Medical Center at Mount Sinai
state: New York
Study officials:
affiliation: Icahn Medical Center at Mount Sinai
name: Max W. Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: