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Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Primary Purpose

Glioblastoma, Astrocytoma, Oligodendroglioma

Status

Completed

Phase

Phase 2

Locations

Turkey

Study Type

Interventional

Intervention

Temozolomide

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Temozolomide, Brain Tumor, Recurrent, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient age >18 years old
Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)
Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging
Karnofsky Performance Status scale >/=50 (due to brain pathology)
Adequate hematological, renal and hepatic function
Patients willing to participate in the study and signing the informed consent

Exclusion Criteria:

Karnofsky Performance Status scale <50
Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study
Patients not suitable for follow-up

Sites / Locations

Marmara University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival at 6-months

Secondary Outcome Measures

Full Information

NCT ID

NCT00575887

First Posted

December 17, 2007

Last Updated

November 3, 2013

Sponsor

Marmara University

Collaborators

Schering-Plough

1. Study Identification

Unique Protocol Identification Number

NCT00575887

Brief Title

Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Official Title

Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marmara University

Collaborators

Schering-Plough

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Tumor, Recurrent

Keywords

Temozolomide, Brain Tumor, Recurrent, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodal, Temodar

Intervention Description

100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity

Primary Outcome Measure Information:

Title

Progression-free Survival at 6-months

Time Frame

Until progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient age >18 years old Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme) Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging Karnofsky Performance Status scale >/=50 (due to brain pathology) Adequate hematological, renal and hepatic function Patients willing to participate in the study and signing the informed consent Exclusion Criteria: Karnofsky Performance Status scale <50 Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study Patients not suitable for follow-up

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ufuk ABACIOGLU, MD

Organizational Affiliation

Marmara University Hospital, Radiation Oncology Department

Official's Role

Study Chair

Facility Information:

Facility Name

Marmara University Hospital

City

Istanbul

ZIP/Postal Code

34660

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

20878446

Citation

Abacioglu U, Caglar HB, Yumuk PF, Akgun Z, Atasoy BM, Sengoz M. Efficacy of protracted dose-dense temozolomide in patients with recurrent high-grade glioma. J Neurooncol. 2011 Jul;103(3):585-93. doi: 10.1007/s11060-010-0423-2. Epub 2010 Sep 29.

Results Reference

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Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

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