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Trial record 66 of 156 for:    "Primary Central Nervous System Lymphoma"

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

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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

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.

Condition or disease Intervention/treatment Phase
Central Nervous System Tumors Drug: Pemetrexe Drug: Temozolomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed and Temozolomide in Treating Patients With Relapsed PCNSL
Study Start Date : March 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015


Arm Intervention/treatment
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).
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01985451


Sponsors and Collaborators
Rongjie Tao
National Natural Science Foundation of China
Investigators
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Study Director: Yong Wang, master Study Director

Publications of Results:
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Responsible Party: Rongjie Tao, Neurosurgery, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01985451     History of Changes
Other Study ID Numbers: ShandongCHI002
ShandongCHI ( Registry Identifier: ShandongCHI )
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

Keywords provided by Rongjie Tao, Shandong Cancer Hospital and Institute:
Lymphoma

Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Temozolomide
Pemetrexed
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors