Status:
TERMINATED
Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
Lead Sponsor:
Max Sung
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
FEMALE
18-85 years
Phase:
PHASE1
Brief Summary
RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studyin...
Detailed Description
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12). OBJECTIVES: * Stud...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed\* breast adenocarcinoma metastatic to the liver
- Solitary or multiple hepatic metastases
- No malignant involvement of \> 40% of the estimated liver volume NOTE: \*Must be from the hepatic tumor designated for study injection
- Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI
- At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance
- Extrahepatic metastasis allowed
- No solitary hepatic metastasis eligible for liver resection
- No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy)
- Hormone-receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Granulocyte count ≥ 1,500/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm\^3
- PT ≤ 14.5 sec
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Transaminases ≤ 2.5 times ULN
- Karnofsky performance status ≥ 70%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment
- No active infection or serious intercurrent medical illness
- No HIV infection
- Life expectancy ≥ 16 weeks
- No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer
- At highest dose level, patient must weigh ≥ 30 kg
- PRIOR CONCURRENT THERAPY:
- No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry
- Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment
- No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00301106
Start Date
October 1 2005
End Date
August 1 2008
Last Update
February 2 2017
Active Locations (1)
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1
Mount Sinai Medical Center
New York, New York, United States, 10029