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NCT00575887 Clinical Trial

Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00575887
Other study ID # MU-RO-2005-1
Secondary ID
Status Completed
Phase Phase 2
First received December 17, 2007
Last updated November 3, 2013
Start date August 2006
Est. completion date March 2009

Study information
Verified date November 2013
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Temozolomide
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

Locations
Country Name City State
Turkey Marmara University Hospital Istanbul

Sponsors (2)
Lead Sponsor Collaborator
Marmara University Schering-Plough

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free Survival at 6-months Until progression No
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