Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
Conditions
Primary Non Hodgkin Lymphoma of the Central Nervous System
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
PCNSL, Lymphoma, Methotrexate, Lomustine, Procarbazine, Rituximab, Elderly, Chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Methotrexate Type: Drug
Name: Lomustine Type: Drug
Name: Procarbazine Type: Drug
Name: Rituximab Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 65 Years
Gender: Both
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
Location
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Freiburg, Germany
Status: Recruiting
Contact: Gerald Illerhaus, PD Dr. - +497612703785 - Gerald.Illerhaus@uniklinik-freiburg.de
Start Date
September 2009
Completion Date
September 2011
Sponsors
University Hospital Freiburg
Source
University Hospital Freiburg
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page