NCT Number: NCT00003278
Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma
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.
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Conditions
Age range
70 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
radiation therapy
RadiationPrimary outcomes
-
overall survival
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study 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)
Important dates
- Study start
- 1998
- Primary completion
- 2003
- Study completion
- 2003
- First posted
- Jan 27, 2003
- Registry last updated
- Jul 6, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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