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Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma
This study has been completed.
Sponsor:
Marmara University
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Ufuk ABACIOGLU, Marmara University
ClinicalTrials.gov Identifier:
NCT00575887
First received: December 17, 2007
Last updated: November 3, 2013
Last verified: November 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent | Drug: Temozolomide | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Temozolomide
Genetic and Rare Diseases Information Center resources:
Glioblastoma
Glioma
Oligodendroglioma
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Ufuk ABACIOGLU, Marmara University:
Primary Outcome Measures:
- Progression-free Survival at 6-months [ Time Frame: Until progression ]
| Enrollment: | 25 |
| Study Start Date: | August 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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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: NCT00575887
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575887
Locations
| Turkey | |
| Marmara University Hospital | |
| Istanbul, Turkey, 34660 | |
Sponsors and Collaborators
Marmara University
Schering-Plough
Investigators
| Study Chair: | Ufuk ABACIOGLU, MD | Marmara University Hospital, Radiation Oncology Department |
More Information
Publications:
| Responsible Party: | Ufuk ABACIOGLU, Assoc. Prof., Marmara University |
| ClinicalTrials.gov Identifier: | NCT00575887 History of Changes |
| Other Study ID Numbers: |
MU-RO-2005-1 |
| Study First Received: | December 17, 2007 |
| Results First Received: | November 3, 2013 |
| Last Updated: | November 3, 2013 |
Keywords provided by Ufuk ABACIOGLU, Marmara University:
|
Temozolomide Brain Tumor, Recurrent Chemotherapy |
Additional relevant MeSH terms:
|
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 Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 21, 2017