Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma

March 27, 2015 updated by: International Extranodal Lymphoma Study Group (IELSG)

Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Oncology Institute of Southern Switzerland (IOSI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histological or cytological diagnosis of non-Hodgkin's lymphoma.
  2. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
  3. Disease exclusively localized into the central nervous system, cranial nerves or eyes.
  4. Untreated patients (patients treated with steroids alone are eligible).
  5. At least one measurable lesion.
  6. Age 18 - 75 years.
  7. ECOG performance status < 3
  8. HBsAg-negative and Ab anti-HCV-negative serologic status.
  9. No known HIV disease or immunodeficiency.
  10. Adequate bone marrow (PLT > 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 mL/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin < 3 mg/dL, AST/ALT and gGT < 2 per upper normal limit value).
  11. No previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).
  12. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  13. Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
  14. No concurrent treatment with other experimental drugs.
  15. Informed consent signed by the patient before registration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High-dose methotrexate alone
Radiation: radiotherapy
Drug: high dose methotrexate
Experimental: High-dose methotrexate associated with high dose cytarabine
Radiation: radiotherapy
Drug: high dose methotrexate
Drug: high dose cytarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The main endpoint is the complete remission (CR) rate after chemotherapy

Secondary Outcome Measures

Outcome Measure
Overall survival
Event-free survival
Overall response rate
Response duration (time to relapse or progression) for responder patients
Meningeal relapse rate
Early and late neurotoxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Investigators

  • Study Chair: Emanuele Zucca, MD, International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
  • Study Chair: Andres JM Ferreri, MD, Radiochemotherapy. San Raffaele Hospital. Milan
  • Study Chair: Michele Reni, MD, Radiochemotherapy. San Raffaele Hospital. Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IELSG20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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