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Anaplastic OligodendrogliomaPhase 2NCT01847235

Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial

A Phase 2 study testing Temozolomide in people with Anaplastic Oligodendroglioma and Anaplastic Oligoastrocytoma, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteSouth Korea
Study dates
May 2013to Mar 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven anaplastic oligodendroglioma or oligoastrocytoma
  • Progressed or relapsed after surgery or radiation therapy
  • Female or male aged 20 years or over
  • At least 1 measurable mass lesion
  • ECOG performance status 0-3
  • Adequate organ function
Show all 12Show fewer
  • absolute neutrophil count > 1,500/μL
  • platelet count > 75,000/μL
  • hemoglobin greater than 9 g/dL or 900g/L
  • serum creatinine less than 1.5 times the upper limit of laboratory normal
  • total serum bilirubin less than 1.5 times the upper limit of laboratory normal
  • AST or ALT less than three times the upper limit of laboratory normal

Who cannot join

  • Prior course of temozolomide
  • Combined glioblastoma
  • Pregnant woman

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial

The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.

Read the detailed description

Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle * 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion.

During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.

Being tested
Temozolomide
Keywords
Temozolomide
Medical subject headings
Oligodendroglioma

What participants receive

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

  • TemozolomideDrug

    Also called Temodal

    Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).

Study groups in NCT01847235
Study groupRoleWhat they receive
TemozolomideExperimentalTemozolomide 200 mg/m2/d in a fasting state for 5 consecutive days
Receives: Drug: Temozolomide

What is being measured

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

  1. Progression free survival (PFS)

    PFS will be examined with Kaplan-Meier method.

    Measured: 6 month

Secondary outcomes (4)

  1. Objective response rate (ORR)

    ORR will be evaluated through the frequency analysis with 95% confidence interval.

    Measured: 1 year

  2. Overall survival (OS)

    OS will be examined with Kaplan-Meier method.

    Measured: 1 years

  3. progression-free survival (PFS)

    PFS will be examined with Kaplan-Meier method.

    Measured: 1 year

  4. Number of Participants with Adverse Events

    Regarding safety endpoints, all adverse events will be individually graded based on the CTCAE version 4.03. The number of participants with adverse events will be summarized using descriptive statistics.

    Measured: 1 years

Timeline

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

  1. First posted6 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2015
  4. Study completionMar 2016

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847235
Sponsor's protocol ID
OD_OA
Status last verified
Apr 2016
First submitted
29 Apr 2013
Last updated
26 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

    PubMed 15758009

  • Perry JR, Rizek P, Cashman R, Morrison M, Morrison T. Temozolomide rechallenge in recurrent malignant glioma by using a continuous temozolomide schedule: the "rescue" approach. Cancer. 2008 Oct 15;113(8):2152-7. doi: 10.1002/cncr.23813.

    PubMed 18756530

  • Perry JR, Belanger K, Mason WP, Fulton D, Kavan P, Easaw J, Shields C, Kirby S, Macdonald DR, Eisenstat DD, Thiessen B, Forsyth P, Pouliot JF. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010 Apr 20;28(12):2051-7. doi: 10.1200/JCO.2009.26.5520. Epub 2010 Mar 22.

    PubMed 20308655

  • Yung WK, Prados MD, Yaya-Tur R, Rosenfeld SS, Brada M, Friedman HS, Albright R, Olson J, Chang SM, O'Neill AM, Friedman AH, Bruner J, Yue N, Dugan M, Zaknoen S, Levin VA. Multicenter phase II trial of temozolomide in patients with anaplastic astrocytoma or anaplastic oligoastrocytoma at first relapse. Temodal Brain Tumor Group. J Clin Oncol. 1999 Sep;17(9):2762-71. doi: 10.1200/JCO.1999.17.9.2762.

    PubMed 10561351

  • Cairncross JG, Ueki K, Zlatescu MC, Lisle DK, Finkelstein DM, Hammond RR, Silver JS, Stark PC, Macdonald DR, Ino Y, Ramsay DA, Louis DN. Specific genetic predictors of chemotherapeutic response and survival in patients with anaplastic oligodendrogliomas. J Natl Cancer Inst. 1998 Oct 7;90(19):1473-9. doi: 10.1093/jnci/90.19.1473.

    PubMed 9776413

  • Van den Bent MJ, Reni M, Gatta G, Vecht C. Oligodendroglioma. Crit Rev Oncol Hematol. 2008 Jun;66(3):262-72. doi: 10.1016/j.critrevonc.2007.11.007. Epub 2008 Feb 12.

    PubMed 18272388

  • Mollemann M, Wolter M, Felsberg J, Collins VP, Reifenberger G. Frequent promoter hypermethylation and low expression of the MGMT gene in oligodendroglial tumors. Int J Cancer. 2005 Jan 20;113(3):379-85. doi: 10.1002/ijc.20575.

    PubMed 15455350

  • Gan HK, Rosenthal MA, Dowling A, Kalnins R, Algar E, Wong N, Benson A, Woods AM, Cher L. A phase II trial of primary temozolomide in patients with grade III oligodendroglial brain tumors. Neuro Oncol. 2010 May;12(5):500-7. doi: 10.1093/neuonc/nop065. Epub 2010 Feb 8.

    PubMed 20406900

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temozolomide in people with Anaplastic Oligodendroglioma and Anaplastic Oligoastrocytoma, run by Seoul National University Hospital at 1 site in South Korea.

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 12 inclusion and 3 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: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression free survival (PFS) (time frame: 6 month). 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 NCT01847235, which also lists 8 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 26 Apr 2016.

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