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Temozolomide in Treatment of Patients With Primary Central Nervous System Lymphoma

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ClinicalTrials.gov Identifier: NCT02934204
Recruitment Status : Unknown
Verified May 2016 by Guangdong General Hospital.
Recruitment status was:  Recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

Brief Summary:
Consolidation treatment for Primary Central Nervous System Diffuse Large B cell Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.

Condition or disease Intervention/treatment Phase
Primary CNS Lymphoma Drug: methotrexate Drug: temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Temozolomide in Treatment of Patients With Primary Central Nervous System Lymphoma
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Experimental: MTX and Temozolomide

Induction therapy:

Methotrexate 3.5g/m2 ivgtt d1 2weeks/cycle,total 8 cycles Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 4 cycles

Consolidation therapy:

PCNSL patients achieve CR,Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 12 cycles

Drug: methotrexate
Drug: temozolomide



Primary Outcome Measures :
  1. event free survival [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. Chronic neurotoxicity [ Time Frame: 3 year ]
  2. Overall survival [ Time Frame: 3 year ]
  3. Completed response [ Time Frame: 3 year ]


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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
Criteria

Inclusion Criteria:

- (1) histology confirmed to be PCNSL. (2) lymphoma invasion in brain, meninges, cerebrospinal fluid, eye organ. (3) ECOG score less than 3 points (4) at least 1 of the lesions can be evaluated with a double diameter. (5) the life expectancy of more than 6 months. (6) less or equal to 75 years,or more or equal to 18 years. (7) to be able to comply with the requirements of the study and follow-up procedures.

(8) to sign the consent form to participate in the study. (9) having adequate organ function, defined as follows: Liver function, serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) equal to or less than 2 times the upper limit of normal (ULN).

Bone marrow function: absolute neutrophil count more or equal to 1500/L, platelet count more than 100000/L,hemoglobin was greater than 9 g/dL.

Renal function, serum creatinine or creatinine clearance rate (less than 1.5ULN Cockcroft-Gault formula based on the improvement of more than 50ml/min).

(10) women with childbearing potential must start to get the test results of serum / urine pregnancy test negative within 48 hours prior to study. Postmenopausal women who have at least 12 months of menopause can be treated as non fertile.

Exclusion Criteria:

  • (1) patients with a history of other malignancies within five years (except for the full treatment of cervical carcinoma in situ or basal cell carcinoma or squamous cell skin cancer).

    (2) had previously been treated with total cranial irradiation. (3) the upper digestive tract is lack of physical integrity, or suffering from malabsorption syndrome, or oral drug, or active gastric ulcer.

    (4) suffering from any unstable systemic diseases (including active infection, significant cardiovascular disease, any significant liver and kidney or metabolic disorders), metabolic disorders, physical examination results or laboratory examination results of contraindication to the use of drugs, or may affect the treatment results of interpretation or increase the risk of complications in treatment of risk (5) patients with human immunodeficiency virus (HIV) transmitted in the form of blood or other body fluids.

    (6) women in pregnancy and lactation. (7) women of childbearing age who do not want to use contraceptive measures during the study period and have sexual capacity of men.

    (8) patients who do not want to sign informed consent. (9) patients who were not willing to follow up. (10) for any drugs or excipients of allergy. Exit the case: no matter what reason patients withdrew from the study of cases in time will be postponed.


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): NCT02934204


Contacts
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Contact: Wenyu Li, MD PhD +86 20 81884713 ext 80411 LiWY1206@163.com
Contact: Sichu Liu, MD PhD +86 20 81884713 ext 80411 sisi.lau@foxmail.com

Locations
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China, Guangdong
Guangdong general hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Sichu Liu, MD PhD    +86 20 81884713 ext 80411    sisi.lau@foxmail.com   
Sponsors and Collaborators
Guangdong General Hospital

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Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT02934204     History of Changes
Other Study ID Numbers: GDREC2015431H(R1)
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Guangdong General Hospital:
PCNSL
DLBCL
methotrexate
temozolomide
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Temozolomide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
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