Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003278

Enrollment

Registered

2003-01-27

Start date

1998-03-31

Completion date

2003-06-30

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma, intraocular lymphoma

Brief summary

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.

Detailed description

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.

Interventions

DRUGdexamethasone

RADIATIONradiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Inclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
overall survival	Up to 5 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026