Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma
This study has been completed.
Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00210314
First received: September 13, 2005
Last updated: July 22, 2009
Last verified: July 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma, B Cell |
Drug: high dose methotrexate Drug: high dose cytarabine Procedure: radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):
Primary Outcome Measures:
- The main endpoint is the complete remission (CR) rate after chemotherapy
Secondary Outcome Measures:
- Overall response rate
- Response duration (time to relapse or progression) for responder patients
- Overall survival
- Event-free survival
- Meningeal relapse rate
- Early and late neurotoxicity
| Enrollment: | 79 |
| Study Start Date: | July 2003 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of non-Hodgkin's lymphoma.
- Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
- Disease exclusively localized into the central nervous system, cranial nerves or eyes.
- Untreated patients (patients treated with steroids alone are eligible).
- At least one measurable lesion.
- Age 18 - 75 years.
- ECOG performance status < 3
- HBsAg-negative and Ab anti-HCV-negative serologic status.
- No known HIV disease or immunodeficiency.
- 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).
- 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).
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
- No concurrent treatment with other experimental drugs.
- Informed consent signed by the patient before registration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210314
Locations
| Switzerland | |
| Oncology Institute of Southern Switzerland (IOSI) | |
| Bellinzona, Switzerland, 6500 | |
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
| 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) |
More Information
Additional Information:
No publications provided by International Extranodal Lymphoma Study Group (IELSG)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | International Extranodal Lymphoma Study Group (IELSG), IELSG |
| ClinicalTrials.gov Identifier: | NCT00210314 History of Changes |
| Other Study ID Numbers: | IELSG20 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 22, 2009 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cytarabine Methotrexate 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 Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013