Randomized Phase III Trial of G-CSF Primed Autologous Bone Marrow Versus Peripheral Blood Progenitor Cells (PBPC) as Hematopoietic Support for High-Dose Cyclophosphamide, Thiotepa, and Carboplatin (CTCb) Therapy in Poor Prognosis Breast Cancer
18 Years
60 Years
Both
Breast Cancer
Trial Information
Randomized Phase III Trial of G-CSF Primed Autologous Bone Marrow Versus Peripheral Blood Progenitor Cells (PBPC) as Hematopoietic Support for High-Dose Cyclophosphamide, Thiotepa, and Carboplatin (CTCb) Therapy in Poor Prognosis Breast Cancer
OBJECTIVES: I. Compare engraftment rates using G-CSF primed autologous bone marrow vs PBCP
as hematopoietic support following high dose CTCb for patients with poor prognosis breast
cancer. II. Compare the complications of these two methods of hematopoietic progenitor cell
collections. III. Compare Stage IV patients with bone or bone marrow involvement (assigned
to PBPC collections) with Stage IV patients randomized to PBPC collections relative to the
number of leukaphereses needed to collect the required number of progenitor cells as well as
assess engraftment rates between these two groups. IV. Assess the response to high dose CTCb
in this group of patients.
OUTLINE: All patients will receive G-CSF priming therapy for 5 consecutive days. Patients
will then be randomized into two treatment arms: Arm 1 consists of autologous PBPC
collection Arm 2 consists of autologous bone marrow collection Within 2 weeks after
progenitor cell collection, all patients will receive high dose CTCb therapy by continuous
infusion for 5 days, followed by autologous hematopoietic progenitor cell infusion at least
three days later. G-CSF will also be given after infusion until ANC count is over 5,000 or
over 1,000 for 3 consecutive days.
PROJECTED ACCRUAL: 66 patients will be accrued at a rate of 24 per year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed Stage IIIB and IV adenocarcinoma of the
breast Stage II-IIIA adenocarcinoma of the breast with poor risk features (including
poorly differentiated histology, high mitotic rate, hormone receptor negative, high S
phase) with at least three involved axillary lymph nodes, estimated five year relapse free
survival rate less than 50%, and does not qualify for higher priority protocol treatments
No central nervous system involvement
PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life
expectancy: Greater than 2 months Hematopoietic: Platelet count greater than 75,000/mm3
Neutrophils greater than 1500/mm3 Hepatic: Serum bilirubin, alkaline phosphatase, and SGOT
or SGPT less than 3 times upper limit of normal, unless due to disease Renal: Serum
creatinine less than 1.5 times upper limit of normal Creatinine clearance at least 60
mL.min Cardiovascular: Ventricular ejection fraction at least 45% No uncontrolled or
severe cardiovascular disease, including recent myocardial infarction, congestive heart
failure, angina, life threatening arrhythmia, or hypertension Pulmonary: DLCO and
spirometry at least 50% of predicted Other: Not HIV positive Not HBsAG positive Not
pregnant Must have functioning central venous catheter No active infection No uncontrolled
diabetes mellitus No other prior malignancy except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II
cancer from which the patient is currently in complete remission, or any other cancer from
which the patient has been disease free for at least 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior hematopoietic progenitor cell support
Chemotherapy: No prior dose intensive therapy Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
David D. Hurd, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CDR0000065391
NCT ID:
NCT00002942
Start Date:
June 1996
Completion Date:
December 2003
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IV breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
