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

NCT ID: NCT01985451

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Central Nervous System Tumors

Keywords

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Pemetrexe

Intervention Type: DRUG

Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m²).

Temozolomide

Intervention Type: DRUG

Patients with relapsed PCNSL patients were treated with temozolomide (200mg/m² day 1-5,28).

Interventions

Pemetrexe

Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m²).

Intervention Type: DRUG

Temozolomide

Patients with relapsed PCNSL patients were treated with temozolomide (200mg/m² day 1-5,28).

Intervention Type: DRUG

Other Intervention Names

Alimta; Temodal

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Rongjie Tao

OTHER

Sponsor Role: lead

Responsible Party

Rongjie Tao

Neurosurgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong Wang, master

Role: STUDY_DIRECTOR

Study Director

References

Raizer JJ, Rademaker A, Evens AM, Rice L, Schwartz M, Chandler JP, Getch CC, Tellez C, Grimm SA. Pemetrexed in the treatment of relapsed/refractory primary central nervous system lymphoma. Cancer. 2012 Aug 1;118(15):3743-8. doi: 10.1002/cncr.26709. Epub 2011 Dec 16.

Reference Type: RESULT

PMID: 22179954 (View on PubMed)

Zhang JP, Lee EQ, Nayak L, Doherty L, Kesari S, Muzikansky A, Norden AD, Chen H, Wen PY, Drappatz J. Retrospective study of pemetrexed as salvage therapy for central nervous system lymphoma. J Neurooncol. 2013 Oct;115(1):71-7. doi: 10.1007/s11060-013-1196-1. Epub 2013 Jul 5.

Reference Type: RESULT

PMID: 23828279 (View on PubMed)

Leshchenko VV, Kuo PY, Jiang Z, Thirukonda VK, Parekh S. Integrative genomic analysis of temozolomide resistance in diffuse large B-cell lymphoma. Clin Cancer Res. 2014 Jan 15;20(2):382-92. doi: 10.1158/1078-0432.CCR-13-0669. Epub 2013 Oct 31.

Reference Type: RESULT

PMID: 24178621 (View on PubMed)

Other Identifiers

ShandongCHI

Identifier Type: REGISTRY

Identifier Source: secondary_id

ShandongCHI002

Identifier Type: -

Identifier Source: org_study_id