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 because the information has not been verified recently.
Verified October 2009 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital Koeln
University Hospital Muenchen
University Hospital Heidelberg
University Hospital Ulm
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00989352
First received: October 2, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 and IPCG testing) [ 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: 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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: 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
University Hospital Koeln
University Hospital Muenchen
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

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
Study First Received: October 2, 2009
Last Updated: October 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Lomustine
Rituximab
Methotrexate
Procarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014