Clinical trial NCT00989352: Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
Official title: Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Non Hodgkin Lymphoma of the Central Nervous System
Keywords: PCNSL
Lymphoma
Methotrexate
Lomustine
Procarbazine
Rituximab
Elderly
Chemotherapy
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Köln
name: Ludwig-Maximilians - University of Munich
name: University Hospital Heidelberg
name: University Hospital Ulm
First posted: 2009-10-05
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Complete remission rate
timeFrame: 30 days after end of immuno-chemotherapy
Secondary outcomes:
measure: Duration of response
timeFrame: within 5 years
measure: Overall survival time
timeFrame: within 5 years
measure: Neuropsychological state (according to Mini-Mental State and IPCG testing)
timeFrame: within 5 years
measure: (Serious) adverse events ([S]AEs)
timeFrame: within 30 days after treatment
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Study officials:
affiliation: University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
name: Gerald Illerhaus, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Illerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26.
citation: Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15.