Phase Ⅱ Trial of Temozolomide Plus Concurrent Whole-Brain Radiation Followed by TNV Regimen as Adjuvant Therapy for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (PCNSL)
20 Years
75 Years
Both
Central Nervous System Tumors
Trial Information
Phase Ⅱ Trial of Temozolomide Plus Concurrent Whole-Brain Radiation Followed by TNV Regimen as Adjuvant Therapy for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (PCNSL)
The best reported outcomes of PCNSL treatment are high-dose methotrexate-based chemotherapy
combined with whole-brain radiation therapy (WBRT). Despite aggressive therapy, however,
nearly 50% of patients will relapse within 24 months of diagnosis. Furthermore, the
application of high-dose methotrexate-based regimen is complex, needing be hydrated,
alkalified and detoxified, and treatment-related toxicity mortality is severe[3,4]. In an
attempt to improve upon these poor results and reduce treatment-related side effects, we
will treat about 15-20 PCNSL patients with temozolomide concurrent chemoradiotherapy at the
outset and then adjuvant chemotherapy for 6 cycles with temozolomide, nedaplatin,
vincristine, as part of front-line therapy. Our objective is to assess our treatment
strategies' availability based on response rates, progression-free survival (PFS), median
PFS, and toxicity.
Inclusion Criteria:
- Histologically confirmed primary CNS lymphoma.
- Newly diagnosed.
- ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
- Relevant hospital examination including laboratory examination and physical
examination (Chest X-ray, electrocardiogram, abdomen B ultrasonography, magnetic
resonance imaging (MRI) of head and neck) must to be done, in order to exclude other
system fatal diseases.
- Must have adequate organ function as defined by the protocol: Adequate renal
function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60
ml/min; Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT & ALST ≤ 1.5 x
ULN.Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet
count ≥ 100,000 /mm^3, hemoglobin ≥ 9 g/dl.
- Age >/= 18 and
- Signed written informed consent prior to study entry.
Exclusion Criteria:
- Patients with human immunodeficiency virus seropositivity and systemic lymphoma
manifestation.
- Serious uncontrolled concurrent illness.
- Previous brain radiotherapy, systemic chemotherapy.
- Concurrent chronic systemic immune therapy, targeted therapy not indicated in this
study protocol.
- Any evidence of prior exposure to Hepatitis B virus.
- Unable to comprehend the study requirements or who are not likely to comply with the
study parameters.
- Pregnant (confirmed by serum or urine β-HCG) or lactating.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of complete radiologic response (CR)
Outcome Description:
final data collection date for primary outcome measure
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Yu-fang Zhu, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Shandong Cancer Hospital and Institute
Authority:
China: Ministry of Health
Study ID:
ShandongCHI 002
NCT ID:
NCT01735747
Start Date:
June 2008
Completion Date:
November 2013
Related Keywords:
- Central Nervous System Tumors
- Lymphoma
- Lymphoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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