Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Nordic Cancer Union
Roche Pharma AG
Mundipharma Pte Ltd.
Schering-Plough
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01458730
First received: September 15, 2011
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.


Condition Intervention Phase
Central Nervous System Lymphoma
Drug: Immunochemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • response rate [ Time Frame: at completion of therapy ] [ Designated as safety issue: No ]
  • neurotoxicity [ Time Frame: 1-10 years after completion of therapy ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: May 2007
Estimated Study Completion Date: October 2020
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Immunochemotherapy
    Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte
Detailed Description:

The objective of the study is

  1. To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
  2. To assess the long term outcome concerning neurotoxicity
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
  • Patients treated with steroids alone are eligible
  • No signs of lymphoma outside the CNS
  • ECOG performance status 0-4
  • Age > 17 and < 76 years
  • Written informed consent from the patient or guardian

Exclusion Criteria:

  • Cardiac failure > 3
  • Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
  • Previous malignancy unless disease free for at least five years
  • Active infection.
  • Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
  • Positive HIV status
  • Organ transplantation
  • Serious psychiatric illness
  • Prior radiotherapy to the brain
  • Concomitant anti-inflammatory medication that cannot be discontinued
  • Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
  • Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
  • Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal.
  • Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study
  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: NCT01458730

Locations
Denmark
Elisa Jacobsen Pulczynski
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Nordic Cancer Union
Roche Pharma AG
Mundipharma Pte Ltd.
Schering-Plough
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01458730     History of Changes
Other Study ID Numbers: EudraCT No 2006-004772-12
Study First Received: September 15, 2011
Last Updated: November 15, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
PCNSL
Immunochemotherapy
Intraspinal Depocyt
Maintenance temozolomide

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014