Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title: Phase II Trial of Sequential High-Dose Alkylating Agents in Metastatic Breast Cancer

Status Completed

Clinical Trial 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 kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of sequential high-dose chemotherapy followed by peripheral stem cell transplantation in treating patients with metastatic breast cancer that is responding to chemotherapy.

Clinical Trial Description

OBJECTIVES: I. Determine the feasibility and efficacy of sequential high-dose cyclophosphamide, melphalan, and thiotepa plus autologous peripheral blood stem cell rescue in patients with metastatic breast cancer with ongoing objective response to prior induction chemotherapy.

OUTLINE: Patients receive sequential therapy beginning with regimen A. Regimen A: Patients receive cyclophosphamide IV over 1 hour every 6 hours or more for 4 doses within 36 hours. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 2 days after completion of cyclophosphamide and continuing until autologous peripheral blood stem cells (PBSC) are harvested. Regimen B: Beginning at least 3 weeks after initiation of regimen A, patients receive melphalan IV on days 1 and 2. Beginning on day 4, a portion of the PBSC are reinfused. Patients receive G-CSF SC daily beginning on day 4 and continuing until at least day 10. Regimen C: Beginning at least 3 weeks after initiation of regimen B, patients receive thiotepa IV over 2 hours on days 1 and 2. Beginning on day 5, the remaining PBSC are reinfused. Patients receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover. During regimens A, B, and C, G-CSF must be discontinued at least 2 days before administration of any chemotherapy. Regimen D: After recovery from chemotherapy, patients with hormone receptor-positive tumors and no prior refractoriness to hormonal therapies receive oral tamoxifen daily, while patients with prior failure on tamoxifen receive oral megestrol 4 times daily. Patients undergo irradiation to sites of prior cutaneous, nodal, bone, or soft tissue bulk disease and resection of residual lesions. Patients are followed weekly for 1 month, biweekly for 2 months, monthly for 5 months, and then bimonthly for 1 year.

PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for this study. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00002680
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: Phase 2
• Start date: February 1994
• Completion date: December 2000