This trial is active, not recruiting.

Conditions breast cancer, metastatic cancer
Treatment adenovirus-mediated human interleukin-12
Phase phase 1
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).