Treatment of Primary CNS Lymphoma
Conditions
Primary CNS Lymphoma (PCNSL)
Conditions: official terms
Lymphoma
Conditions: Keywords
primary CNS lymphoma;chemotherapy;, RR;PFS;OS
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HD-MTX-Ara-C regimen Type: Drug
Name: FVD regimen Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the efficacy and safety of FVD regiment (fotemustine, teniposide and dexamethasone ) for patients with primary CNS lymphoma.
Detailed Description
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with PCNSL remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. The purpose of this study is to evaluate the efficacy and safety of FVD regiment(fotemustine, teniposide and dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 14 Years
Gender: Both
Criteria: Inclusion Criteria:Age range 14-60 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed PCNSL None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent. -

Exclusion Criteria:Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato

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Location
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Status: Recruiting
Contact: Mingzhi Zhang, Pro,Dr - 13838565629 - mingzhi_zhang@126.com
Start Date
June 2012
Completion Date
June 2020
Sponsors
Mingzhi Zhang
Source
Zhengzhou University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page