Lymphoma Clinical Trial
Official title:
Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to
give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral
stem cell transplantation in treating patients who have recurrent or refractory 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.
;
Masking: Open Label, Primary Purpose: Treatment
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