Know Cancer

or
forgot password

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)


Phase 2
70 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

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 CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303