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)
70 Years
N/A
Both
Lymphoma
Trial Information
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)
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.
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
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
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
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to the brain or head and neck region
Surgery:
- No prior transplantations (renal, hepatic, or cardiac)
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Brian P. O'Neill, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000066184
NCT ID:
NCT00003278
Start Date:
March 1998
Completion Date:
Related Keywords:
- Lymphoma
- primary central nervous system non-Hodgkin lymphoma
- intraocular lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
