Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00575887 |
Recruitment Status :
Completed
First Posted : December 18, 2007
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent | Drug: Temozolomide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
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
Other Names:
|
- Progression-free Survival at 6-months [ Time Frame: Until progression ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575887
Turkey | |
Marmara University Hospital | |
Istanbul, Turkey, 34660 |
Study Chair: | Ufuk ABACIOGLU, MD | Marmara University Hospital, Radiation Oncology Department |
Responsible Party: | Ufuk ABACIOGLU, Assoc. Prof., Marmara University |
ClinicalTrials.gov Identifier: | NCT00575887 |
Other Study ID Numbers: |
MU-RO-2005-1 |
First Posted: | December 18, 2007 Key Record Dates |
Results First Posted: | December 20, 2013 |
Last Update Posted: | December 20, 2013 |
Last Verified: | November 2013 |
Temozolomide Brain Tumor, Recurrent Chemotherapy |
Glioblastoma Brain Neoplasms Astrocytoma Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |