Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 analyze whether patients who have undergone primary chemotherapy can postpone irradiation with its possible late sequelae until recurrence without incurring losses in progression-free and overall survival. This is studied here for the first time worldwide in a systematic, controlled and randomized manner. In this study, one arm with six cycles of high-dose MTX and subsequent irradiation (A1), which comes closest to a "standard arm of primary therapy", at least according to the majority assessment, is compared to irradiation at recurrence with regard to time to progression and overall survival (A2). In primary therapy failure, it will also be analyzed to what extent salvage therapy with AraC is equivalent to irradiation as the "standard arm" with regard to time to progression and overall survival (arm B1 and B2).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: University Hospital Tuebingen
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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