Breast Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation
or peripheral stem cell transplantation may allow the doctor to give higher doses of
chemotherapy drugs and kill more tumor cells.
PURPOSE: Randomized phase III trial to compare bone marrow transplantation with peripheral
stem cell transplantation following carboplatin in treating patients with 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.
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