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A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (TIME) Followed by Autologous Stem Cell Rescue in Metastatic Breast Cancer
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: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous peripheral stem cell transplantation in treating women who have metastatic breast cancer.
OBJECTIVES: I. Evaluate the efficacy and toxicity of high dose topotecan with ifosfamide and etoposide followed by autologous peripheral blood stem cell rescue in women with metastatic breast cancer. II. Evaluate the response rates, progression free survival, engraftment, and nonrelapse related mortality in women treated with this regimen. III. Evaluate the pharmacokinetic profile of high dose topotecan with respect to the efficacy and toxicity of ifosfamide and etoposide in these women. OUTLINE: Peripheral blood stem cells (PBSC) are harvested from the patient and stored. Patients receive ifosfamide IV over 2 hours and topotecan IV over 30 minutes on days -8 to -6, and etoposide IV daily over 24 hours on days -5 to -3. Autologous PBSC are reinfused on day 0. Patients are followed at 1, 3, 6, and 12 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study over 2 years.
Age
18 - 64 years
Sex
FEMALE
Healthy Volunteers
No
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Start Date
March 1, 2000
Primary Completion Date
April 1, 2001
Completion Date
April 1, 2001
Last Updated
December 11, 2012
etoposide
DRUG
ifosfamide
DRUG
topotecan hydrochloride
DRUG
peripheral blood stem cell transplantation
PROCEDURE
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
NCT05245812
NCT05673200
Data Source & Attribution
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