Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
- Determine the morbidity, mortality, and overall outcome in patients with hematologic
malignancies, breast cancer, or other chemosensitive solid tumors treated with
disease-specific dose-intensive conditioning regimens and autologous peripheral blood
or bone marrow transplantation.
OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk
includes acute leukemia in first relapse or second remission; lymphoma in responding first
relapse or second remission; or breast cancer at risk for recurrence. High risk includes all
others. Patients receive specific conditioning regimens according to diagnosis as outlined
- Regimen A (standard risk non-Hodgkin's lymphoma and under 60 years of age)-Etoposide,
cyclophosphamide, and total body irradiation (TBI) (VCT): Patients receive etoposide IV
continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on
day -4. Patients undergo TBI on days -3 to -1.
- Regimen B (any risk Hodgkin's lymphoma and under 60 years of age)-Cyclophosphamide,
carmustine, and etoposide (CBV): Patients receive etoposide IV continuously over 34
hours beginning on day -8; cyclophosphamide IV over 2 hours on days -7 to -4; and
carmustine IV over 2 hours on day -3.
- Regimen C (any risk patient with prior exposure to high-dose etoposide and
cyclophosphamide and under 60 years of age)-Melphalan and TBI (MEL/TBI): Patients
receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.
- Regimen D (multiple myeloma or amyloidosis)-Melphalan only (MEL only): Patients receive
melphalan IV over 30 minutes on day -2.
- Regimen E (any patient unable to receive TBI)-Busulfan and cyclophosphamide: Patients
receive oral busulfan (or busulfan IV over 2 hours) on days -7 to -4 and
cyclophosphamide IV over 2 hours on days -3 and -2.
- Regimen F (any risk breast cancer)-Cyclophosphamide, carboplatin, and thiotepa (STAMP
V): Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours,
and thiotepa IV over 24 hours on days -7 to -4.
- Regimen G (solid tumors other than breast or testicular cancer)-Thiotepa and
carboplatin (TT/CARBO): Patients receive thiotepa IV over 2 hours on days -6 and -5 and
carboplatin IV continuously over 96 hours beginning on day -6.
- Regimen H (recurrent or primary progressive testicular cancer)-Etoposide and
carboplatin (VP/CARBO): Patients receive etoposide IV over 2 hours and carboplatin IV
over 30 minutes on days -6 to -4.
Stem Cell Infusion
- In all regimens, patients undergo autologous stem cell infusion on day 0. Treatment
continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen)
will be accrued for this study within 10 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Philip L. McCarthy, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|