NCT00004900

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	anastrozole
DRUG	carboplatin
DRUG	cisplatin
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	thiotepa
PROCEDURE	peripheral blood stem cell transplantation
RADIATION	radiation therapy

Timeline

• Start date: 1999-10-01
• Completion: 2004-08-01
• First posted: 2004-08-20
• Last updated: 2013-05-30

Locations

1 site across 1 country: United States