Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pemetrexed and Temozolomide in Treating Patients With Relapsed Primary Central Nervous System Lymphoma (PCNSL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01985451
Recruitment Status : Unknown
Verified November 2013 by Rongjie Tao, Shandong Cancer Hospital and Institute.
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Rongjie Tao, Shandong Cancer Hospital and Institute

Tracking Information
First Submitted Date  ICMJE November 4, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date November 15, 2013
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
complete response (CR) [ Time Frame: 2 years ]
Contrast MRI was performed to assess treatment response at 3-month interval for 2 years and thereafter every 6 months for next 3-5 years and then annually. The treatment response was reassessed according to International PCNSL Collaborative Group' criteria[1]. [1] Abrey LE, Batchelor TT, Ferreri AJ, Gospodarowicz M, Pulczynski EJ, Zucca E, et al. Report of an international workshop to standardize baseline evaluation and response criteria for primary CNS lymphoma. International Primary CNS Lymphoma Collaborative Group. J Clin Oncol 2005;23:5034-43.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
  • Failure-free survival (PFS) [ Time Frame: 2 years ]
    Contrast MRI was performed to assess treatment response. PFS was defined as the time from initial diagnosis until disease progression. PFS and median PFS were analyzed using the Kaplan-Meier product limit curve.
  • Toxicity [ Time Frame: 2 years ]
    Toxicity was graded according to the Word Health Organization (WHO) classification. For example:hematotoxicity,nausea,fatigue, abnormal liver function, alopecia, peripheral nerve damage, and constipation et al.
  • Overall response rate (ORR) [ Time Frame: 2 years ]
    The disease control rate,This is the equivalent to Overall response rate, was (CR+ PR+SD).CR:complete respons; PR:partial response; SD:stable disease.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed and Temozolomide in Treating Patients With Relapsed Primary Central Nervous System Lymphoma (PCNSL)
Official Title  ICMJE Phase II Trial of Pemetrexed and Temozolomide in Treating Patients With Relapsed PCNSL
Brief Summary In this trial, we will treat relapsed PCNSL with temozolomide, pemetrexed. Our objective was to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.
Detailed Description 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. In an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 relapsed PCNSL patients who was fail in high-dose methotrexate-based chemotherapy. Our objective is to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Central Nervous System Tumors
Intervention  ICMJE
  • Drug: Pemetrexe
    Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m²).
    Other Name: Alimta
  • Drug: Temozolomide
    Patients with relapsed PCNSL patients were treated with temozolomide (200mg/m² day 1-5,28).
    Other Name: Temodal
Study Arms  ICMJE Experimental: Pemetrexed and Temozolomide
Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m2) and temozolomide (200mg/m² day 1-5, 28 day cycle).
Interventions:
  • Drug: Pemetrexe
  • Drug: Temozolomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed primary CNS lymphoma.
  • ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
  • Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease.
  • Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI.
  • Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment.
  • No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast.
  • No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry.
  • No ocular lymphoma by slit lamp examination.
  • 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 </= 75 years.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01985451
Other Study ID Numbers  ICMJE ShandongCHI002
ShandongCHI ( Registry Identifier: ShandongCHI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rongjie Tao, Shandong Cancer Hospital and Institute
Study Sponsor  ICMJE Rongjie Tao
Collaborators  ICMJE National Natural Science Foundation of China
Investigators  ICMJE
Study Director: Yong Wang, master Study Director
PRS Account Shandong Cancer Hospital and Institute
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP