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

NCT01985451 | Unknown Phase 2 DMC

• 2 other identifiers: ShandongCHI002ShandongCHI
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Nervous System Tumors

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (1)

• complete response (CR)

  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.

  2 years

Secondary Outcomes (3)

• Failure-free survival (PFS)

  2 years

• Toxicity

  2 years

• Overall response rate (ORR)

  2 years

Study Arms (1)

Pemetrexed and Temozolomide

EXPERIMENTAL

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; Drug: Temozolomide

Interventions

Pemetrexe DRUG

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

Also known as: Alimta

Pemetrexed and Temozolomide

Temozolomide DRUG

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

Also known as: Temodal

Pemetrexed and Temozolomide

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rongjie Tao: lead
• National Natural Science Foundation of China: collaborator

Related Publications (3)

• 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.

  PMID: 22179954 RESULT

• 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.

  PMID: 23828279 RESULT

• 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.

  PMID: 24178621 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Lymphoma

Interventions

Pemetrexed; Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Yong Wang, master

  Study Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgery

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 15, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 15, 2013

Record last verified: 2013-11