Clinical trial · Interventional
Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma
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)
NCT00003278CI-TRIAL-00022875completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiation + dexamethasone
- description
- 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.
- interventionNames
- Drug: dexamethasone
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (3)
- BACKGROUNDO'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. PMID 10523802
- RESULTLaack 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. PMID 16863926
- RESULTLaack 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.