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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01847235
Collaborator
(none)
23
Enrollment
1
Location
1
Arm
34
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Temozolomide

Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [6 month]

      PFS will be examined with Kaplan-Meier method.

    Secondary Outcome Measures

    1. Objective response rate (ORR) [1 year]

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

    2. Overall survival (OS) [1 years]

      OS will be examined with Kaplan-Meier method.

    3. progression-free survival (PFS) [1 year]

      PFS will be examined with Kaplan-Meier method.

    4. Number of Participants with Adverse Events [1 years]

      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.

    Other Outcome Measures

    1. Predictive biomarker study [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • 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

    Exclusion Criteria:

    • Prior course of temozolomide

    • Combined glioblastoma

    • Pregnant woman

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Study Chair: Tae Min Kim, MD, PhD, Seoul National University Hospital, Seoul, South Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tae Min Kim, Associate Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01847235
    Other Study ID Numbers:
    • OD_OA
    First Posted:
    May 6, 2013
    Last Update Posted:
    Apr 26, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Tae Min Kim, Associate Professor, Seoul National University Hospital
    Temozolomide
    Additional relevant MeSH terms:
    Oligodendroglioma
    Temozolomide

    Study Results

    No Results Posted as of Apr 26, 2016