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
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Tumors||Drug: Pemetrexe Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m²).
Other Name: Alimta
Patients with relapsed PCNSL patients were treated with temozolomide (200mg/m² day 1-5,28).
Other Name: Temodal
- 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.
 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985451
|Study Director:||Yong Wang, master||Study Director|