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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
David D. Hurd, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center||Winston-Salem, North Carolina 27157-1082|