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

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. Identifier: NCT00210314
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 30, 2015
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Lymphoma, B Cell Drug: high dose methotrexate Drug: high dose cytarabine Radiation: radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007

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

Primary Outcome Measures :
  1. The main endpoint is the complete remission (CR) rate after chemotherapy

Secondary Outcome Measures :
  1. Overall response rate
  2. Response duration (time to relapse or progression) for responder patients
  3. Overall survival
  4. Event-free survival
  5. Meningeal relapse rate
  6. Early and late neurotoxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00210314

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Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
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Study Chair: Andres JM Ferreri, MD Radiochemotherapy. San Raffaele Hospital. Milan
Study Chair: Michele Reni, MD Radiochemotherapy. San Raffaele Hospital. Milan
Study Chair: Emanuele Zucca, MD International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: International Extranodal Lymphoma Study Group (IELSG), IELSG Identifier: NCT00210314     History of Changes
Other Study ID Numbers: IELSG20
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiviral Agents
Anti-Infective Agents