Anaplastic Large Cell Lymphoma Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine,
and cisplatin, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and
yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the
ability of cancer cells to grow and spread. Others find cancer cells and help kill them or
carry cancer-killing substances to them without harming normal cells. Giving more than one
drug (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab
tiuxetan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with
relapsed or refractory AIDS-related non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
- 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
(ESHAP).
- 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.
Secondary
- 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
(HAART).
- 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
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