Freiburg ZNS-NHL Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00647049
First received: March 26, 2008
Last updated: November 16, 2009
Last verified: November 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: within 5 years ] [ Designated as safety issue: No ]
  • Overall survival time [ Time Frame: within 5 years ] [ Designated as safety issue: No ]
  • Neuropsychological state according to Mini-Mental State [ Time Frame: within 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Dr. G. Illerhaus, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00647049     History of Changes
Other Study ID Numbers: ZNS-00465
Study First Received: March 26, 2008
Last Updated: November 16, 2009
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Methotrexate
Thiotepa
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014