Status:
COMPLETED
Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
University Hospital Tuebingen
Conditions:
Central Nervous System Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the study is to deliver primary systemic high-dose methotrexate (MTX) treatment to PCNSL patients and to define the role of whole brain irradiation (WBI) in primary therapy, i.e., to analyz...
Detailed Description
Six 14-day cycles of high-dose MTX will be given at the beginning of the study. Randomization will be performed centrally at the study headquarters in UKBF Berlin already at study inclusion. Patients ...
Eligibility Criteria
Inclusion
- Histologically or cytologically/immunocytologically confirmed primary non-Hodgkin's lymphoma of the CNS. A central reference pathological report will be made on inclusion into the study (Prof. Dr. Pietsch, Reference Center for Brain Tumors of the German Society for Neuropathology and Neuroanatomy, Institute of Neuropathology of the Bonn University Hospital). Histological diagnosis is usually performed by preferential stereotactic biopsy of suspicious lesions in the brain or spinal cord. The diagnosis from cerebrospinal fluid (CSF) requires the detection of malignant lymphocytes according to cytological and immunocytological criteria. There should be no more than 2 weeks between establishing the diagnosis and inclusion in the study. The availability of the reference pathological report is not absolutely necessary for inclusion in the study and beginning therapy.
- Aged \> 18 years
- Life expectancy of at least 2 months
- Adequate bone marrow reserve with a peripheral granulocyte count of \> 1,500/µl and thrombocyte count of \> 100,000/µl; bilirubin in the normal range; GOT of \< three times the upper normal limit and adequate renal function with a creatinine clearance of \> 50 ml/min and serum creatinine in the normal range.
- Written informed consent
- In women of child-bearing age, pregnancy is excluded, effective contraception is necessary, and women should not be breast feeding.
Exclusion
- Manifestation of lymphoma outside of the CNS
- Severe diseases in other organs which would make performing intensive chemotherapy impossible; Karnofsky index \> 50% due to previous diseases other than PCNSL. Karnofsky \> 30 will be accepted only due to the PCNSL.
- Active infection
- HIV positivity
- Previous treatment of PCNSL other than with corticosteroids, antiepileptics or diuretics
- Previous radiotherapy of the brain
- Concomitant or previous malignant diseases in the last 5 years except for an adequately treated basal cell carcinoma or cervical carcinoma in situ
- Immunosuppression, concomitant immunosuppressive therapy, or organ transplantation
- Ongoing chemotherapy for another disease
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT00153530
Start Date
May 1 2000
End Date
May 1 2009
Last Update
December 24 2009
Active Locations (1)
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1
Charite Campus Benjamin Franklin
Berlin, Germany, 12200