Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborators: Ludwig-Maximilians - University of Munich; Universitätsklinikum Köln; University Hospital Heidelberg; University Hospital Ulm
• Treatments: Lomustine; Methotrexate; Procarbazine; Rituximab

Criteria

Inclusion Criteria:

• first diagnosis of PCNSL, histologically confirmed

• age > 65 years

• written signed and dated informed consent of the legal representative and - if possible - of the patient

Exclusion Criteria:

• manifestations of further lymphoma outside the CNS

• sero-positive for HIV

• severe pulmonary, cardiac, hepatic, renal impairment

• uncontrolled infection

• neutrophil count < 1.500/µl, platelet count < 100.000/µl

• pulmonary disease with IVC < 55%, DLCO < 40%

• cardiac ejection fraction < 50%, uncontrolled malign arrhythmia

• creatinine > 1,5 mg% or creatinine-clearance < 50ml/min

• bilirubin > 2mg/dl

• ascites or pleural effusion (> 500ml)

• known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone

• participation in another clinical trial within the last 30 days prior to the begin or parallel to this study

• known or current drug or alcohol abuse