Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00003278 |
|
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 6, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 28 participants |
| 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 : | March 1998 |
| Actual Primary Completion Date : | June 2003 |
| Actual Study Completion Date : | June 2003 |
| 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 |
- overall survival [ Time Frame: Up to 5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003278
| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CentraCare Health Plaza | |
| Saint Cloud, Minnesota, United States, 56303 | |
| United States, North Dakota | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Study Chair: | Brian P. O'Neill, MD | Mayo Clinic |
Publications of Results:
Other Publications:
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00003278 History of Changes |
| Other Study ID Numbers: |
NCCTG-967351 CDR0000066184 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | July 6, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Alliance for Clinical Trials in Oncology:
|
primary central nervous system non-Hodgkin lymphoma intraocular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone BB 1101 Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |