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Central Nervous System TumorsPhase 2NCT01985451

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

A Phase 2 study testing Pemetrexe and Temozolomide in people with Central Nervous System Tumors, run by Rongjie Tao.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Central Nervous System Tumors
What is being tested?
Pemetrexe and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Mar 2013to Mar 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

About this study

Official title: Phase II Trial of Pemetrexed and Temozolomide in Treating Patients With Relapsed PCNSL

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.

Read the 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.

Being tested
Pemetrexe, Temozolomide
Keywords
Lymphoma
Medical subject headings
Central Nervous System Neoplasms, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemetrexeDrug

    Also called Alimta

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

  • TemozolomideDrug

    Also called Temodal

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

Study groups in NCT01985451
Study groupRoleWhat they receive
Pemetrexed and TemozolomideExperimentalPatients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m2) and temozolomide (200mg/m² day 1-5, 28 day cycle).
Receives: Drug: Pemetrexe; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (3)

  1. Failure-free survival (PFS)

    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.

    Measured: 2 years

  2. Toxicity

    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.

    Measured: 2 years

  3. Overall response rate (ORR)

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2015 (estimated)
  4. Study completionMar 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01985451
Sponsor's protocol ID
ShandongCHI002
Other IDs
ShandongCHI
Status last verified
Nov 2013
First submitted
4 Nov 2013
Last updated
15 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22179954

  • 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.

    PubMed 23828279

  • 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.

    PubMed 24178621

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexe and Temozolomide in people with Central Nervous System Tumors, run by Rongjie Tao.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response (CR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01985451, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.

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