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NCT Number: NCT00003278

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

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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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexamethasone

Drug

radiation therapy

Radiation

Primary outcomes

  1. overall survival

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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)

Important dates

Study start
1998
Primary completion
2003
Study completion
2003
First posted
Jan 27, 2003
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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