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

Primary Non Hodgkin Lymphoma of the Central Nervous System Clinical Trial

— PRIMAIN  

Official title:

Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00989352
• Other study ID #: 00591
• Secondary ID: Eudract: 2008-00
• Status: Recruiting
• Phase: Phase 2
• First received: October 2, 2009
• Last updated: October 2, 2009
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2009
• Source: University Hospital Freiburg
• Contact: Gerald Illerhaus, PD Dr.
• Phone: +497612703785
• Email: Gerald.Illerhaus[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Primary Non Hodgkin Lymphoma of the Central Nervous System

Intervention

Drug:
• Methotrexate
3g/m² i.v. max. 9 times
• Lomustine
110 mg/m² p.o., max. 3 times
• Procarbazine
60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times
• Rituximab
375 mg/m² i.v., max. 10 times

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology	Freiburg

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Freiburg	Ludwig-Maximilians - University of Munich, Universitätsklinikum Köln, University Hospital Heidelberg, University Hospital Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Illerhaus G, Marks R, Müller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate		30 days after end of immuno-chemotherapy	No
Secondary	Duration of response		within 5 years	No
Secondary	Overall survival time		within 5 years	No
Secondary	Neuropsychological state (according to Mini-Mental State and IPCG testing)		within 5 years	Yes
Secondary	(Serious) adverse events ([S]AEs)		within 30 days after treatment	Yes

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