Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
This trial is active, not recruiting.
|Conditions||breast cancer, metastatic cancer|
|Treatment||adenovirus-mediated human interleukin-12|
|Sponsor||Mount Sinai School of Medicine|
|Start date||October 2005|
|Trial size||36 participants|
|Trial identifier||NCT00301106, CDR0000456626, MTS-9911-358, MTS-A-8200, MTS-GCO-97-779|
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 studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.
Female participants from 18 years up to 85 years old.
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)
|Official title||Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver|
|Description||OBJECTIVES: - Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer. - Determine tumor responses produced by this regimen. - Determine immune responses induced by this regimen. OUTLINE: This is a dose-escalation study. Patients receive adenovirus-mediated human interleukin-12 via percutaneous intratumoral needle puncture under ultrasound guidance on day 1. Cohorts of 3-6 patients receive escalating doses of adenovirus-mediated human interleukin-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.|
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