Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT00003278

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 14 Locations for this study

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CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
Siouxland Hematology-Oncology
Sioux City Iowa, 51101, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CentraCare Health Plaza
Saint Cloud Minnesota, 56303, United States
Medcenter One Health System
Bismarck North Dakota, 58501, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57709, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT00003278

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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