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

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ClinicalTrials.gov Identifier: NCT00989352
Recruitment Status : Unknown
Verified October 2009 by University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : October 5, 2009
Last Update Posted : October 5, 2009
Sponsor:
Collaborators:
Universitätsklinikum Köln
Ludwig-Maximilians - University of Munich
University Hospital Heidelberg
University Hospital Ulm
Information provided by:
University Hospital Freiburg

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
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
Study Start Date : September 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources


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


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

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


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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

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

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 Posted: October 5, 2009    Key Record Dates
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