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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


Phase 3
18 Years
60 Years
Not Enrolling
Both
Breast Cancer

Thank you

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 CenterWinston-Salem, North Carolina  27157-1082