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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000066184 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiation + dexamethasone | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug |
| ||
| radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Up to 5 years |
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DISEASE CHARACTERISTICS:
Pathologically confirmed non-Hodgkin's lymphoma with intracranial lesions
Measurable or evaluable disease by CT scan or MRI
No neoplastic meningitis or gross spinal cord involvement
PATIENT CHARACTERISTICS:
Age:
Performance status:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Brian P. O'Neill, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10523802 | Background | 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. doi: 10.1007/BF02906134. | |
| 16863926 | Result | 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 (NCCTG) 96-73-51. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1429-39. doi: 10.1016/j.ijrobp.2006.03.061. |
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|
| Jacksonville |
| Florida |
| 32224 |
| United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61602 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| Siouxland Hematology-Oncology | Sioux City | Iowa | 51101-1733 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CentraCare Health Plaza | Saint Cloud | Minnesota | 56303 | United States |
| Medcenter One Health System | Bismarck | North Dakota | 58501 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57709 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57104 | United States |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Result | 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 Cancer Treatment Group (NCCTG) 967351. [Abstract] Neuro-Oncology 6 (4): RT-11, 361, 2004. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D064090 | Intraocular Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D013812 | Therapeutics |
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