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:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00849459
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00849459
Study Brief:
Protocol Section:
NCT00849459