Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate

Criteria

DISEASE CHARACTERISTICS:

• Stage IV breast cancer

• Measurable disease

• Progressive disease

• Increase in disease mass or less than partial response to therapy

• At least one prior chemotherapy regimen for metastatic disease and progressed

• Must have received prior therapy with a taxane and an anthracycline

• Estrogen/progesterone receptor-positive patients must have received and progressed on at least one hormonal agent in adjuvant or metastatic setting

• Her2-neu-expressing patients must have received and progressed on trastuzumab (Herceptin®) in adjuvant or metastatic setting

• Prior autologous stem cell transplantation allowed if less than complete response or disease progression in adjuvant or metastatic setting

• Consenting first-degree relative with at least 5 out of 6 HLA-antigen match (may include mismatch at the D locus)

• Hormone receptor status:

• Estrogen receptor status known

• Progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 80-100%

Life expectancy:

• More than 6 months

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin ≤ 2 mg/dL

• SGOT < 4 times upper limit of normal

• Hepatitis B surface antigen negative

• Hepatitis C antibody negative

Renal:

• Creatinine ≤ 1.5 mg/dL

• Creatinine clearance ≥ 50 mL/min

Cardiovascular:

• Left ventricular ejection fraction > 45%

Pulmonary:

• DLCO ≥ 50% of predicted

Other:

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• Recovered from prior stem cell transplantation

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• See Disease Characteristics

• No concurrent steroids

Radiotherapy:

• Not specified

Surgery:

• Not specified