Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease
- Determine the 3-year progression-free survival of patients with progressive or
recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation
(2 courses of high-dose therapy with autologous stem cell rescue).
- Determine the response rate in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to risk (poor risk
[primary progressive, recurrent, or resistant relapse] vs good risk [first recurrence]).
- Salvage therapy (for patients with relapsed disease after achieving a previous complete
response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.
- Autologous hematopoietic stem cell collection: Patients undergo autologous
hematopoietic stem cell collection. Patients with an inadequate number of collected
stem cells are removed from the study.
- First preparative regimen: Patients receive high-dose melphalan IV continuously over 16
hours on day -1.
- First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on
day 0. They also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on
day 5 and continuing until blood counts recover. At least 4-8 weeks later, patients
proceed to second preparative regimen.
- Second preparative regimen: Patients receive high-dose carmustine IV over 1-2 hours on
days -6, -5, and -4, etoposide IV over 4 hours on day -3, and cyclophosphamide IV over
2 hours on day -2. Beginning 36-48 hours later, patients proceed to the second
autologous SCT (day 0).
- Second autologous SCT: Patients undergo second autologous SCT on day 0. Patients also
receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and
continuing until blood counts recover.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 3 years
Up to three years after second transplant
Brian J. Bolwell, MD
Cleveland Clinic Taussig Cancer Institute
United States: Institutional Review Board
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|