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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by University Hospital Freiburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989352
First Posted: October 5, 2009
Last Update Posted: October 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universitätsklinikum Köln
Ludwig-Maximilians - University of Munich
University Hospital Heidelberg
University Hospital Ulm
Information provided by:
University Hospital Freiburg
  Purpose
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.

Condition Intervention Phase
Primary Non Hodgkin Lymphoma of the Central Nervous System Drug: Methotrexate Drug: Lomustine Drug: Procarbazine Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Complete remission rate [ Time Frame: 30 days after end of immuno-chemotherapy ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: within 5 years ]
  • Overall survival time [ Time Frame: within 5 years ]
  • Neuropsychological state (according to Mini-Mental State and IPCG testing) [ Time Frame: within 5 years ]
  • (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ]

Estimated Enrollment: 56
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Methotrexate
    3g/m² i.v. max. 9 times
    Drug: Lomustine
    110 mg/m² p.o., max. 3 times
    Drug: Procarbazine
    60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times
    Drug: Rituximab
    375 mg/m² i.v., max. 10 times
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989352


Contacts
Contact: Gerald Illerhaus, PD Dr. +497612703785 Gerald.Illerhaus@uniklinik-freiburg.de
Contact: Elvira Burger +497612707378 elvira.burger@uniklinik-freiburg.de

Locations
Germany
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology Recruiting
Freiburg, Germany, 79106
Contact: Gerald Illerhaus, PD Dr.    +497612703785    Gerald.Illerhaus@uniklinik-freiburg.de   
Contact: Elvira Burger    +497612707378    elvira.burger@uniklinik-freiburg.de   
Principal Investigator: Gerald Illerhaus, PD Dr.         
Sponsors and Collaborators
University Hospital Freiburg
Universitätsklinikum Köln
Ludwig-Maximilians - University of Munich
University Hospital Heidelberg
University Hospital Ulm
Investigators
Principal Investigator: Gerald Illerhaus, PD Dr. University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
  More Information

Additional Information:
Publications:
Responsible Party: PD Dr. Gerald Illerhaus,, University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
ClinicalTrials.gov Identifier: NCT00989352     History of Changes
Other Study ID Numbers: 00591
Eudract: 2008-007645-31
First Submitted: October 2, 2009
First Posted: October 5, 2009
Last Update Posted: October 5, 2009
Last Verified: October 2009

Keywords provided by University Hospital Freiburg:
PCNSL
Lymphoma
Methotrexate
Lomustine
Procarbazine
Rituximab
Elderly
Chemotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Methotrexate
Lomustine
Procarbazine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents