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Trial record 2 of 27 for:    "Central Nervous System Lymphoma" | "Topoisomerase Inhibitors"

Treatment of Primary CNS Lymphoma (FVD)

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ClinicalTrials.gov Identifier: NCT01960192
Recruitment Status : Recruiting
First Posted : October 10, 2013
Last Update Posted : July 21, 2015
Sponsor:
Collaborator:
Zhengzhou University
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

Brief 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.

Condition or disease Intervention/treatment Phase
Primary CNS Lymphoma (PCNSL) Drug: HD-MTX-Ara-C regimen Drug: FVD regimen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prospective Study of FVD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.
Study Start Date : June 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: FVD regimen
FVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.
Drug: FVD regimen
FVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles

Experimental: HD-MTX-Ara-C regimen
high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.
Drug: HD-MTX-Ara-C regimen
high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks ) ]
  2. overall survival [ Time Frame: up to the date of death (approximately 5 years) ]
  3. median survival time [ Time Frame: 24 months ]


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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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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 ClinicalTrials.gov identifier (NCT number): NCT01960192


Contacts
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Contact: Mingzhi zhang, Pro,Dr 13838565629 Mingzhi_zhang@126.com

Locations
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China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr    13838565629    mingzhi_zhang@126.com   
Sponsors and Collaborators
Mingzhi Zhang
Zhengzhou University
Investigators
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Principal Investigator: Mingzhi Zhang, Pro,Dr The First Affiliated Hospital of Zhengzhou University

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Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT01960192     History of Changes
Other Study ID Numbers: hnslblzlzx2011-6
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Mingzhi Zhang, Zhengzhou University:
primary CNS lymphoma;chemotherapy;
RR;PFS;OS

Additional relevant MeSH terms:
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Topoisomerase Inhibitors
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Fotemustine
Teniposide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Enzyme Inhibitors