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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00003278

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: dexamethasone Radiation: radiation therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: radiation + dexamethasone 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.	Drug: dexamethasone Radiation: radiation therapy

Arm

Intervention/Treatment

Experimental: radiation + dexamethasone

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.

Drug: dexamethasone

Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

overall survival [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Mayo Clinic	Jacksonville	Florida	United States	32224
3	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
6	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
7	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
8	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
9	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
10	CentraCare Health Plaza	Saint Cloud	Minnesota	United States	56303
11	Medcenter One Health System	Bismarck	North Dakota	United States	58501
12	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
13	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
14	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1