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)
dexamethasone
+ radiation therapy
Eye Neoplasms+8
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: March 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
CCOP - Scottsdale Oncology Program
Scottsdale, United StatesOpen CCOP - Scottsdale Oncology Program in Google MapsMayo Clinic
Jacksonville, United StatesCCOP - Illinois Oncology Research Association
Peoria, United StatesCCOP - Carle Cancer Center
Urbana, United States