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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Se-Hoon Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01847235
First received: April 29, 2013
Last updated: May 23, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    PFS will be examined with Kaplan-Meier method.


Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    ORR will be evaluated through the frequency analysis with 95% confidence interval.

  • Overall survival (OS) [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    OS will be examined with Kaplan-Meier method.

  • progression-free survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    PFS will be examined with Kaplan-Meier method.

  • Number of Participants with Adverse Events [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
    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:
  • Predictive biomarker study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Temodal

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847235

Contacts
Contact: Se-Hoon Lee, MD, PhD +82-2-2072-1672 shlee119@snu.ac.kr

Locations
Korea, Republic of
Se-Hoon Lee Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Se-Hoon Lee         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Se-Hoon Lee, MD, PhD    +82-2-2072-0832    lungonco@gmail.com   
Principal Investigator: Se-Hoon Lee         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Se-Hoon LEE, MD, PhD Seoul National University Hospital, Seoul, South Korea
  More Information

Publications:

Responsible Party: Se-Hoon Lee, Clinical Professor (Associate Professor), Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01847235     History of Changes
Other Study ID Numbers: OD_OA
Study First Received: April 29, 2013
Last Updated: May 23, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Temozolomide

Additional relevant MeSH terms:
Oligodendroglioma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014