A Phase II Pilot Study of Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support Without Conventional-Dose Induction Chemotherapy for Women With Metastatic Breast Cancer
OBJECTIVES: I. Assess the toxicity and response rates to sequential high dose chemotherapy
without induction chemotherapy in women with metastatic breast cancer. II. Determine the
hematopoietic recovery rate in these patients after infusion of blood derived CD34+
progenitors isolated using a CD34+ affinity device for positive purification of the
autograft. III. Compare response rates and duration of responses between these patients
treated in this trial to patients treated in a previous trial using the same sequential high
dose chemotherapy with induction conventional dose chemotherapy.
OUTLINE: Patients receive cyclophosphamide IV daily for 2 days, and etoposide IV and
cisplatin IV daily for 3 days. Filgrastim (G-CSF) is administered subcutaneously twice daily
beginning 24 hours after completion of chemotherapy until the last day of apheresis. Upon
hematopoietic recovery, peripheral blood stem cells (PBSC) are collected over several days.
Within 35 days of mobilization chemotherapy, patients receive cyclophosphamide IV, thiotepa
IV, and carboplatin IV continuously on days -7 to -4, followed by a 2 day rest period. CD34+
selected PBSC are reinfused. Beginning 4 hours after reinfusion, patients receive G-CSF
subcutaneously daily until hematopoietic recovery. Patients may then receive radiation
therapy to sites of prior bulk disease at the discretion of the investigator. Within 30 days
of hematopoietic recovery or immediately following post transplant radiation therapy,
patients receive oral anastrazole daily until disease progression. Patients are followed
monthly for 6 months, every 3 months for 1 year, every 4-6 months for 5 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Andrew L. Pecora, MD, FACP
Study Chair
Hackensack University Medical Center Cancer Center
United States: Federal Government
NU-HAC98B2
NCT00004900
October 1999
August 2004
Name | Location |
---|---|
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |