Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
- Determine the overall survival rate at one year in patients with relapsed or refractory
AIDS-related non-Hodgkin's lymphoma treated with consolidation therapy comprising
rituximab and yttrium Y 90 ibritumomab tiuxetan (radioimmunotherapy) given after
induction therapy comprising etoposide, methylprednisolone, cytarabine, and cisplatin
- Describe the toxicity profile of radioimmunotherapy as consolidation therapy, including
changes in immunologic and virologic parameters over time, in these patients.
- Determine the overall disease-free survival of patients receiving ESHAP as induction
therapy followed by radioimmunotherapy as consolidation therapy.
- Determine the effect of ESHAP as induction therapy and radioimmunotherapy as
consolidation therapy on HIV-1 viral load, CD4 and CD8 cells, and quantitative
immunoglobulin levels in patients on concurrent highly active antiretroviral therapy
- Determine the objective response rates (complete and partial response) in patients
treated with this regimen.
- Determine the toxicity of ESHAP as induction therapy in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive ESHAP chemotherapy comprising etoposide IV over 2
hours on days 1-4, methylprednisolone IV over 15-30 minutes on days 1-5, cisplatin IV
continuously over 96 hours on days 1-4, and cytarabine IV over 2 hours on day 5.
Treatment repeats every 21-28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity. Approximately 21-52 days after completion of
ESHAP chemotherapy, patients proceed to consolidation therapy.
- Consolidation therapy: Patients receive radioimmunotherapy comprising rituximab IV over
3-4 hours followed by indium In 111 ibritumomab tiuxetan (for radioimaging) IV over 10
minutes on day 1. Patients then undergo imaging on days 1 and 2. If biodistribution is
acceptable, patients receive rituximab IV over 3-4 hours followed by yttrium Y 90
ibritumomab tiuxetan IV over 10 minutes on day 8.
After completing study treatment, patients are followed every 2 months for 1 year and then
every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Primary Purpose: Treatment
Alexandra M. Levine, MD
USC/Norris Comprehensive Cancer Center
United States: Federal Government