Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma
Status: | Completed |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 70 - Any |
Updated: | 4/21/2016 |
Start Date: | March 1998 |
End Date: | June 2003 |
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.
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.
- 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.
DISEASE CHARACTERISTICS:
- Pathologically confirmed non-Hodgkin's lymphoma with intracranial lesions
- Intraocular lymphoma eligible, if not sole site of disease
- No occult systemic lymphoma
- Measurable or evaluable disease by CT scan or MRI
- No neoplastic meningitis or gross spinal cord involvement
PATIENT CHARACTERISTICS:
Age:
- 70 and over
Performance status:
- ECOG 0-3
Other:
- No prior history of lymphoma
- No other active malignancy except basal cell skin cancer or carcinoma in situ of the
cervix
- HIV negative
- No active peptic ulcer disease
- No uncontrolled diabetes mellitus
- No active pancreatitis
- No active bleeding
- No poorly controlled major psychiatric illness
- No serious uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow transplantation
Chemotherapy:
- No prior chemotherapy
Radiotherapy:
- No prior radiotherapy to the brain or head and neck region
Surgery:
- No prior transplantations (renal, hepatic, or cardiac)
We found this trial at
14
sites
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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