Lymphoma Clinical Trial
Official title:
Primary Central Nervous System Non-Hodgkins's Lymphoma (PCNSL): A Phase II Clinical Trial of Radiation Therapy and High Dose Corticosteroids for Elderly Patients (70 Years of Age and Older)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Combining
radiation therapy with a corticosteroid, such as dexamethasone, may be an effective
treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy and high-dose
dexamethasone in treating older patients with primary CNS non-Hodgkin's lymphoma.
OBJECTIVES:
- Assess the effectiveness of high-dose dexamethasone after whole-brain radiotherapy in
maintaining response and preventing recurrence in elderly patients with primary central
nervous system non-Hodgkin's lymphoma.
- Assess the toxic effects of this regimen in these patients.
- Assess the survival rate of patients after this regimen.
- Identify the anatomic rates of recurrence and frequency of systemic involvement in
patients treated with this regimen.
- Identify the factors that appear to be associated with outcome in patients treated with
this regimen.
OUTLINE: Patients undergo whole-brain radiotherapy (WBRT) daily 5 days a week for 4.5 weeks.
Beginning 30 days after WBRT is completed, patients receive high-dose dexamethasone IV on
days 1-5 during course 1 and on day 1 only during all subsequent courses. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month after radiotherapy, every 3 months for 2 years, every 6
months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 6 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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