Status:
UNKNOWN
a Phase II Study in Primary Central Nervous System Lymphoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Mackay Memorial Hospital
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Detailed Description
5 PATIENT SELECTION 5.1 Eligibility Criteria Patients must fulfill all the following criteria to be eligible for admission for the study: 1. Histologically proven central nervous system lymphoma of ...
Eligibility Criteria
Inclusion
- Patients must fulfill all the following criteria to be eligible for admission for the study:
- Histologically proven central nervous system lymphoma of brain parenchyma with or without leptomeningeal involvement.
- No evidence of systemic lymphoma.
- Age between 18 years and 75 years.
- 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.
- 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.
- No prior malignancy (excluding in situ carcinoma of the cervix or non- melanomatous skin cancer) unless disease free for at least 5 years.
- Signed informed consent.
- Patients must be accessible for treatment and follow-up.
Exclusion
- Patient meets any of the following will be excluded form the study.
- Patients who are seropositive for HIV, AIDS, use of immunosuppressant or who are post organ transplant are not eligible.
- Previously treated with chemotherapy, radiotherapy or other investigational agents. Patients with corticosteroid use are considered eligible.
- With ocular involvement or with any lesion beyond brain parenchyma except leptomeningeal.
- Pregnant, or lactating patients; patients of childbearing potential must implement adequate contractive measures during study participation.
- 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.
- Concurrent treatment with any other experimental drugs.
- \-
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00455286
Start Date
November 1 2006
End Date
November 1 2011
Last Update
April 4 2007
Active Locations (4)
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1
Changhua Christian Hospital
Changhua, Taiwan
2
China Medical University Hospital
Taichung, Taiwan
3
National Cheng Kung University Hospital
Tainan, Taiwan
4
Mackay Memorial Hospital
Taipei, Taiwan