Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating patients who have breast cancer. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Combining chemotherapy with gene therapy may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

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