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a Phase II Study 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: NCT00455286
Recruitment Status : Unknown
Verified April 2007 by National Health Research Institutes, Taiwan.
Recruitment status was:  Recruiting
First Posted : April 3, 2007
Last Update Posted : April 4, 2007
National Taiwan University Hospital
Mackay Memorial Hospital
China Medical University Hospital
National Cheng-Kung University Hospital
Chi Mei Medical Hospital
Taichung Veterans General Hospital
Information provided by:
National Health Research Institutes, Taiwan

Brief Summary:

In this study we will test the hypothesis that concurrent chemoradiation (CCRT) with temozolomide after induction chemotherapy by conventional high-dose methotrexate (HD-MTX) plus dexamethasone may be an effective and well tolerated treatment for immunocompetent patients with PCSNL. Corticosteroid can effectively reduce brain edema and corticosteroid alone has resulted in complete or partial remission in about 40% patients with PCNSL. To enhance local disease control, CCRT with temozolomide will be used in the study. Temozolomide is a well-tolerated oral alkylating agent that is able to permeate the BBB. Concurrent temozolomide with WBRT has shown superior effect to WBRT alone for the treatment of metastatic brain tumors and glioblastoma multiforme. In addition, temozolomide has single-agent activity for PCNSL (21% CR in relapsed or refractory PCNSL in a phase II trial).

This is an open-label, non-randomized, multi-center phase II study. The primary end point of is the complete response rate. This study is a two-stage design for testing non-inferiority of the proposed treatment as compared to the approximately 80% response rate reported for conventional treatment. Assuming a non-inferiority margin of 20%, a sample size of 25 subjects, which provides an 80% power for establishment of non-inferiority. At the first stage, 15 subjects are to be enrolled. If equal to or more than 6 patients achieve complete response, the study would accrue additional 10 subjects. The treatment regimen is as follows.

Induction chemotherapy: MS regimen (repeated every 14 days, total 4 cycles)

  • Methotrexate 3.5 g/m2 i.v. infusion 4 hours on day1
  • Methylprednisolone 200 mg/m2/day i.v. infusion 30 minutes, on day1-4 Concurrent chemoradiotherapy (CCRT)
  • Whole brain radiation therapy (WBRT) 2 Gy per fraction daily, 5 days per week Temozolomide 75 mg/m2/day orally daily, only on the days of WBRT

Condition or disease Intervention/treatment Phase
Primary Central Nervous System Lymphoma Drug: Methotrexate Drug: Methylprednisolone Drug: Temozolomide Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-Dose Methotrexate Plus Steroid Followed by Concurrent Whole Brain Chemoradiation With Temozolomide for Immunocompetent Patients With Primary Central Nervous System Lymphoma – a Phase II Study
Study Start Date : November 2006
Estimated Study Completion Date : November 2011

Primary Outcome Measures :
  1. Primary : To evaluate objective tumor response rate

Secondary Outcome Measures :
  1. Secondary : To assess toxicity profile
  2. To assess time to disease progression

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:

Patients must fulfill all the following criteria to be eligible for admission for the study:

  1. Histologically proven central nervous system lymphoma of brain parenchyma with or without leptomeningeal involvement.
  2. No evidence of systemic lymphoma.
  3. Age between 18 years and 75 years.
  4. With at least one measurable lesion, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 10 mm. See Section 10.2.1 for the evaluation of measurable disease.
  5. Laboratory requirements :

    • Hematology: Neutrophils≧ 1500/mm3, Hemoglobin≧ 10 g/dL, and Platelet count≧ 100000/mm3.
    • Hepatic function: Total bilirubin level≦ 1.5x upper normal limit (UNL), ALT (SGPT) and AST (SGOT)≦ 2.5 x UNL.
    • Renal function: Creatinine≦ 1.5 mg/dL.
  6. No prior malignancy (excluding in situ carcinoma of the cervix or non- melanomatous skin cancer) unless disease free for at least 5 years.
  7. Signed informed consent.
  8. Patients must be accessible for treatment and follow-up.

Exclusion Criteria:

Patient meets any of the following will be excluded form the study.

  1. Patients who are seropositive for HIV, AIDS, use of immunosuppressant or who are post organ transplant are not eligible.
  2. Previously treated with chemotherapy, radiotherapy or other investigational agents. Patients with corticosteroid use are considered eligible.
  3. With ocular involvement or with any lesion beyond brain parenchyma except leptomeningeal.
  4. Pregnant, or lactating patients; patients of childbearing potential must implement adequate contractive measures during study participation.
  5. Other serious illness or medical conditions:

    • Congestive heart failure or unstable angina pectoris. High risk uncontrolled arrhythmias.
    • Uncontrolled infection (active serous infections that are not controlled by antibiotics.
  6. Concurrent treatment with any other experimental drugs.


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): NCT00455286

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Contact: Yueh-Ling Ho, RN 886-2-87923311 ext 17642
Contact: Ching-Hung Lin, M.D. 886-2-2312-3456 ext 2859

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Changhua Christian Hospital Recruiting
Changhua, Taiwan
Contact: Cheng-Shyong Chang, M.D.    886-4-7238595   
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Chang-Fang Chiu Chiu, M.D.    886-4-22052121   
National Cheng Kung University Hospital Recruiting
TaiNan, Taiwan
Contact: Wu-Chou Su, M.D.    886-6-2353535   
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Ming-Chih Chang, M.D.    886-2-25433535 ext 3454   
Contact: Ming-Jer Huang         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Mackay Memorial Hospital
China Medical University Hospital
National Cheng-Kung University Hospital
Chi Mei Medical Hospital
Taichung Veterans General Hospital
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Principal Investigator: Ching-Hung Lin, M.D. National Taiwan University Hospital
Study Chair: Ann-Lii Cheng, Ph.D. National Taiwan University Hospital

Layout table for additonal information Identifier: NCT00455286     History of Changes
Other Study ID Numbers: T1406
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007
Keywords provided by National Health Research Institutes, Taiwan:
CNS Lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
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
Antineoplastic Agents, Alkylating
Alkylating Agents
Anti-Inflammatory Agents
Autonomic Agents