Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Melphalan; Paclitaxel; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin

• Diagnosis within the past 6 months

PATIENT CHARACTERISTICS:

Age:

• 60 and under

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 mg/dL

• SGOT or SGPT no greater than 1.5 times the upper limit of normal

Renal:

• Creatinine less than 1.2 mg/dL

• Creatinine clearance at least 80 mL/min

• No history of hemorrhagic cystitis

Cardiovascular:

• Left ventricular fraction at least 55% on MUGA scan

• No previous valvular heart disease or arrhythmia

Pulmonary:

• FEV_1 at least 60% predicted

• Room air pO_2 greater than 85 mmHg

• Room air pCO_2 no greater than 43 mmHg

• DLCO at least 60% of the lower limit of predicted value

Other:

• No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer

• No organic CNS dysfunction

• Not pregnant

• No known and potentially disabling psychosocial history

• Not positive for hepatitis B or HIV

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Stratum 1:

• No more than one cycle of chemotherapy

• Stratum 2:

• No greater than 225 mg/m^2 doxorubicin and no greater than 250 mg/m^2 paclitaxel during previous chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiation to the left chest wall

Surgery:

• Modified radical mastectomy allowed