Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT00301106
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00301106
Study Brief:
Protocol Section:
NCT00301106