High-Dose Chemotherapy and Autologous Blood Cell Transplantation in Treating Patients With Primary, Locally Advanced, or Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2002-11-01
• 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 and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose mitoxantrone, thiotepa, and cyclophosphamide plus autologous peripheral stem cell transplantation and amifostine in treating patients with primary, locally advanced, or stage IV breast cancer.

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

Details

• Lead Sponsor: University of Arizona
• Treatments: Amifostine; Cyclophosphamide; Mitoxantrone; Thiotepa

Criteria

DISEASE CHARACTERISTICS: Histologically proven primary, locally advanced (at least 10 axillary lymph node metastases or T4 or N2, M0 disease), or stage IV breast cancer Patients with at least 10 axillary node metastases and no distant metastases receive adjuvant chemotherapy with a doxorubicin containing regimen Patients with T4 or N2, M0 disease and no prior chemotherapy receive neoadjuvant or induction chemotherapy prior to salvage mastectomy (patients must show partial remission based on tumor palpation) Patients with stage IV breast cancer receive induction chemotherapy with doxorubicin (unless relapsed less than 1 year following therapy or metastatic disease progression observed or greater than 300 mg/m2 previously taken, then may receive induction chemotherapy with paclitaxel regimen) Stage IV cancer patients must have at least a partial remission following induction chemotherapy Stage IV cancer patients should have minimal metastatic disease (chest wall recurrence or bone only); patients with more extensive and/or visceral metastases must have near complete remission following induction chemotherapy

PATIENT CHARACTERISTICS: Age: 16 to 70 Performance Status: SWOG 0-1 Karnofsky 80-100% Life Expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 times upper limit of normal (ULN) (unless tumor related) SGOT and SGPT less than 2.0 times ULN (unless tumor related) Alkaline phosphatase less than 2.0 times ULN (unless tumor related) Renal: Creatinine within institutional normal limits Cardiovascular: Cardiac ventricular ejection fraction (MUGA) or echocardiogram within normal limits prior to high dose chemotherapy No uncontrolled or severe cardiovascular disease No myocardial infarction within 6 months No congestive heart failure No symptomatic angina No life threatening arrhythmias No hypertension Pulmonary: Pulmonary function tests greater than 75% predicted normal Room air arterial blood gases within normal limits Other: Not HIV positive Not hepatitis B surface antigen positive Not hepatitis C antibody positive No serious organ dysfunction (unless caused by breast cancer) No active bacterial, viral, or fungal infections No active peptic ulcers No uncontrolled diabetes Not pregnant Effective contraceptive method must be used during study Negative pregnancy test

PRIOR CONCURRENT THERAPY: See Disease Characteristics