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

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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.

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
353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Bismarck, North Dakota 58501
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Bismarck, ND
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Cedar Rapids, Iowa 52403
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Cedar Rapids, IA
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300 East Locust St., Ste 350
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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Des Moines, IA
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Peoria, IL
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Regina, Saskatchewan
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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Saint Cloud, Minnesota 56303
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Saint Cloud, MN
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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Sioux City, Iowa 51101
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Sioux City, IA
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Sioux Falls, South Dakota 57104
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Sioux Falls, SD
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Wichita, Kansas 67214
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Wichita, KS
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