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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003278
• Other study ID #: NCCTG-967351
• Secondary ID: CDR0000066184
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 1, 2016
• Start date: March 1998
• Est. completion date: June 2003

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• dexamethasone

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Mayo Clinic	Jacksonville	Florida
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CentraCare Health Plaza	Saint Cloud	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Laack NN, Ballman KV, Brown PB, O'Neill BP; North Central Cancer Treatment Group. Whole-brain radiotherapy and high-dose methylprednisolone for elderly patients with primary central nervous system lymphoma: Results of North Central Cancer Treatment Group — View Citation

Laack NN, Ballman KV, Brown PD, et al.: Toxicity of whole-brain radiotherapy (WBRT) and high-dose methylprednisolone (HDMP) for elderly patients (70 years of age and older) with primary central nervous system lymphoma (PCNSL): results of North Central Can

O'Neill BP, Habermann TM, Witzig TE, Rodriguez M. Prevention of recurrence and prolonged survival in primary central nervous system lymphoma (PCNSL) patients treated with adjuvant high-dose methylprednisolone. Med Oncol. 1999 Sep;16(3):211-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		Up to 5 years	No