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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma



Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma

For Condition: primary central nervous system lymphoma
Status: No longer recruiting
Sponsor(s): EORTC Lymphoma Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.
Details: OBJECTIVES: I. Determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-AIDS related primary central nervous system lymphoma. II. Assess the response rate and safety of this chemotherapy regimen. PROTOCOL OUTLINE: Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging. Methotrexate (MTX) IV is administered over 40-60 minutes on days 1 and 15. Cytarabine (AraC) is administered intrathecally on days 1 and 15. The second course of chemotherapy begins on day 29 or after bone marrow recovery. Radiation therapy begins no later than 3 weeks after completing chemotherapy. Patients are followed until death. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/60 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven non-Hodgkin's lymphoma of the central nervous system (CNS) including leptomeninges and the spinal cord - No Burkitt's lymphoma or low grade T-cell lymphoma - Must have at least 1 measurable lesion - No AIDS-related primary central nervous system lymphoma (PCNSL) - No disease confined to the eye without other localization in the CNS --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent treatment with immunosuppressive drug - Chemotherapy: No prior chemotherapy - Endocrine therapy: Corticosteroid use for less than 3 weeks allowed - Radiotherapy: Not specified - Surgery: No prior organ transplantation --Patient Characteristics-- - Age: 16 to 60 - Performance status: Karnofsky 40-100%; Neurological functional status 0-3 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: No serious impairment of hepatic function - Renal: No serious impairment of renal function; Creatinine no greater than 1.5 mg/dL OR Creatinine clearance no less than 50 mL/min - Cardiovascular: No serious impairment of cardiac function - Other: HIV negative; No congenital or acquired immunodeficiency syndrome; No prior/concurrent systemic lymphoma; No prior malignancy except: Adequately treated non-melanoma skin cancer; Carcinoma in situ of the cervix uteri; Not pregnant; No severe uncontrolled infection
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PatriceCarde,  Study Chair,  EORTC Lymphoma Cooperative Group

Rotterdam Cancer Institute
Rotterdam,  ,  3075 EA
Netherlands
 

Academisch Ziekenhuis Maastricht
Maastricht,  ,  6202 AZ
Netherlands
 

Academisch Ziekenhuis Utrecht
Utrecht,  ,  3508 GA
Netherlands
 

Institut Gustave Roussy
Villejuif,  ,  F-94805
France
 

U.Z. Gasthuisberg
Leuven,  ,  B-3000
Belgium
 

Dr. Bernard Verbeeten Instituut
Tilburg,  ,  5042 SB
Netherlands
 

Atrium Medical Centre
HEERLEN,  ,  6419 PC
Netherlands
 


Additional Information:
Study ID Numbers:
  CDR0000065724;  EORTC-20962
Study Start Date: July 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003061

Other Primary Central Nervous System Lymphoma Studies:
1. Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

2. Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma

3. Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

4. Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

5. Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma

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