Status:
COMPLETED
Gene Therapy in Treating Women With Metastatic Breast Cancer
Lead Sponsor:
Max Sung
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 be...
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 tumo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00849459
Start Date
August 1 2008
End Date
June 1 2011
Last Update
January 11 2017
Active Locations (1)
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1
Icahn Medical Center at Mount Sinai
New York, New York, United States, 10029