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Freiburg ZNS-NHL Study

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 November 2009 by University Hospital Freiburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647049
First Posted: March 31, 2008
Last Update Posted: November 17, 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.
Collaborator:
University Hospital Tuebingen
Information provided by:
University Hospital Freiburg
  Purpose
The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].

Condition Intervention Phase
Primary Non Hodgkin Lymphoma of the Central Nervous System Drug: methotrexate Drug: Rituximab Drug: Cytarabine Drug: Thiotepa Drug: Carmustin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: 30 days after blood stem cell transplantation ]

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 [ Time Frame: within 5 years ]
  • Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20) [ Time Frame: within 5 years ]
  • (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ]

Estimated Enrollment: 78
Study Start Date: January 2007
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
first diagnosis of PCNSL: combined chemotherapy with methotrexate
Drug: methotrexate
8000mg/m2 i.v., max. 2 cycles
Other Name: MTX
Drug: Rituximab
375mg/m2, max. 8 times
Drug: Cytarabine
3000mg/m2 die i.v., 2 days (max. 2 cycles)
Other Name: Arabinoside
Drug: Thiotepa
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
Drug: Carmustin
400mg/m2 i.v. for 1 day
Other Names:
  • BCNU
  • Bis-Chlorethyl-Nitrosourea
Experimental: B
Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
Drug: Rituximab
375mg/m2, max. 8 times
Drug: Cytarabine
3000mg/m2 die i.v., 2 days (max. 2 cycles)
Other Name: Arabinoside
Drug: Thiotepa
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
Drug: Carmustin
400mg/m2 i.v. for 1 day
Other Names:
  • BCNU
  • Bis-Chlorethyl-Nitrosourea

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • group A: first diagnosis of PCNSL, histologically confirmed
  • group B: relapse or progression of PCNSL after MTX containing chemotherapy
  • age 18 - 65 years
  • not legally incompetent, physically or mentally incapable of giving consent
  • 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
  • neutrophil count < 2.000/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)
  • pregnancy o r lactation
  • women with childbearing potential without sufficient contraception
  • 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
  • known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
  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): NCT00647049


Contacts
Contact: Gerald Illerhaus, Dr. 00497612703785 Gerald.Illerhaus@uniklinik-freiburg.de
Contact: Andreas Zähringer, Dr. 00497612707370 andreas.zaehringer@uniklinik-freiburg.de

Locations
Germany
University Hospital Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Gerald Illerhaus, Dr.    00497612703785    Gerald.Illerhaus@uniklinik-freiburg.de   
Contact: Andreas Zähringer    00497612707378    andreas.zaehringer@uniklinik-freiburg.de   
Sponsors and Collaborators
University Hospital Freiburg
University Hospital Tuebingen
Investigators
Principal Investigator: Jürgen Finke, Prof. Dr. University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. G. Illerhaus, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00647049     History of Changes
Other Study ID Numbers: ZNS-00465
First Submitted: March 26, 2008
First Posted: March 31, 2008
Last Update Posted: November 17, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Methotrexate
Cytarabine
Thiotepa
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
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating