Lymphoma Clinical Trial
Official title:
Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study
RATIONALE: Drugs used in chemotherapy 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, 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. Giving rituximab together with combination chemotherapy
may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and best ways to give combination
chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS
lymphoma.
OBJECTIVES:
Primary
- Determine the rate of toxicity, in terms of percentage of patients with grade 4
neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction
therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and
temozolomide followed by consolidation therapy comprising cytarabine and etoposide
phosphate.
Secondary
- Determine the efficacy of this regimen, in terms of the 4-month and 12-month complete
and best response rate, in these patients.
- Determine the progression-free and overall survival of patients treated with this
regimen.
- Determine the percentage of patients experiencing toxicity or neurotoxicity due to this
regimen.
- Determine the treatment-related mortality rate in patients treated with this regimen.
- Document the neurocognitive changes in these patients using the Mini-Mental Status
Examination during the first year of treatment with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive high-dose methotrexate IV over 4 hours on days
1,15, 29, 43, 57, 71, and 99; leucovorin calcium IV every 6 hours on days 2-4, 16-18,
30-32, 44-46, 58-60, 72-74, and 100-102; oral temozolomide on days 7-11, 35-39, 63-67,
91-95, and 119-123; and rituximab IV on days 3, 17, 31, 45, 59, and 74. Treatment
continues in the absence of disease progression or unacceptable toxicity. Patients who
achieve complete response proceed to consolidation therapy.
- Consolidation therapy I: Beginning 3-4 weeks after completing induction therapy,
patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin calcium IV
every 6 hours on days 2-4, and oral temozolomide on days 7-11.
- Consolidation therapy II: Beginning 3-5 weeks after completing consolidation therapy I,
patients receive cytarabine IV over 2 hours twice daily and etoposide phosphate IV
continuously on days 1-4 and filgrastim (G-CSF) subcutaneously beginning on day 14 and
continuing until blood counts recover.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued to this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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