This Phase 1 trial by the National Cancer Institute (NCI) studied the effectiveness of combining gene therapy with chemotherapy in patients with breast cancer. It used the Ad5CMV-p53 gene, based on the idea that inserting the p53 gene into cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Participants were over 18 with histologically confirmed epithelial breast cancer and at least 3 cutaneous or subcutaneous lesions; the trial is completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * Histologically confirmed epithelial breast cancer * At least 3 cutaneous or subcutaneous lesions required * Measurable disease that includes, but is not limited to, cutaneous or subcutaneous metastases PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-2 * Absolute granulocyte count at least 1,500/mm3 * Hemoglobin greater than 8 g/dL * Platelet count greater than 100,000/mm3 * Bilirubin less than 2 mg/dL * PT/PTT within normal range * SGOT/SGPT less than 2 times upper limit of normal * Creatinine less than 1.8 mg/dL * Not pregnant * Fertile patients must use effective contraception during and for 3 months after therapy PRIOR CONCURRENT THERAPY: * Concurrent cytotoxic chemotherapy allowed, if stable and responding * At least 4 weeks since prior chemotherapy, if starting a new regimen * At least 4 weeks since radiotherapy * Prior adjuvant radiotherapy to the chest wall allowed * At least 6 months since radiotherapy to lesions that are to be injected * Recovered from prior therapy