Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease|
- Progression-free survival at 3 years [ Time Frame: Up to three years after second transplant ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: Up to one year after second transplant ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Up to one year after second transplant ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2002|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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.
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Brian J. Bolwell, MD||Cleveland Clinic Taussig Cancer Institute|