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
18 Years
65 Years
Female
Breast Cancer
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of the breast
metastatic to any organ except brain, including ipsilateral supraclavicular (not axillary)
lymph nodes and chest wall No apocrine, adenocystic, squamous cell carcinoma, sarcoma, or
lymphoma Measurable or evaluable disease No stage IV disease rendered nonassessable by
surgery No symptomatic CNS disease Hormone receptor status: Must have biological and/or
immunocytochemical receptor assays for estrogen and progesterone reported
PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater
than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 3.0
mg/dL SGOT no greater than 6 times upper limit of normal Renal: Not specified
Cardiovascular: Ejection fraction at least 40% by MUGA No angina pectoris requiring active
nitrate therapy No myocardial infarction within the past 6 months No uncontrolled
congestive heart failure, uncontrolled hypertension, or major ventricular arrhythmia
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No active infection or medical condition that would preclude administration
of high dose therapy No other prior malignancy within the past 5 years except inactive
nonmelanoma skin cancer or carcinoma in situ of the cervix No uncompensated endocrine
dysfunction HIV negative Hepatitis B negative
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior course of adjuvant therapy No other prior chemotherapy for metastatic breast cancer
At least 6 months since prior adjuvant therapy No cumulative doxorubicin equivalent dose
or greater than 360 mg/m2 in the adjuvant setting Endocrine therapy: Prior hormonal
therapy for metastatic disease allowed Radiotherapy: Not specified Surgery: See Disease
Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Andrew L. Pecora, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Hackensack University Medical Center Cancer Center
Authority:
United States: Federal Government
Study ID:
NU-HAC98B2
NCT ID:
NCT00004900
Start Date:
October 1999
Completion Date:
August 2004
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
