Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma
OBJECTIVES:
- Determine the safety and tolerability of intensive chemotherapy and autologous
peripheral blood stem cell transplantation in patients with recurrent or refractory
AIDS-related lymphoma.
- Determine the response and response duration in these patients treated with this
regimen.
- Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these
patients.
OUTLINE: Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2
hours followed 2 days later by daily filgrastim (G-CSF) subcutaneously (SC) until blood
counts recover. Patients then undergo leukopheresis to collect CD34+ cells.
Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days
-7, -6, -5, and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3
and -2. Patients undergo autologous stem cell infusion on day 0. G-CSF is administered IV or
SC daily beginning on day 1 and continuing until blood counts recover.
Patients are followed monthly for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
David T. Scadden, MD
Study Chair
Massachusetts General Hospital
United States: Federal Government
CDR0000067835
NCT00005824
November 2000
April 2006
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |