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| Sponsors and Collaborators: |
Marmara University School of Medicine Schering-Plough |
|---|---|
| Information provided by: | Marmara University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00575887 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-Grade Gliomas |
| Estimated Enrollment: | 25 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | February 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ufuk ABACIOGLU, MD | 90 216 327 6956 | ufuka@marmara.edu.tr |
| Contact: Hale B CAGLAR, MD | 90 216 327 1010 ext 431 | halebasakcaglar@gmail.com |
| Turkey | |
| Marmara University Hospital | Recruiting |
| Istanbul, Turkey, 34660 | |
| Contact: Ufuk ABACIOGLU, MD 90 216 3276956 ufuka@marmara.edu.tr | |
| Contact: Fulden YUMUK, MD 90 216 3271010 ext 474 fuldenyumuk@superonline.com | |
| Principal Investigator: Ufuk ABACIOGLU, MD | |
| Sub-Investigator: Hale B CAGLAR, MD | |
| Sub-Investigator: Fulden YUMUK, MD | |
| Study Chair: | Ufuk ABACIOGLU, MD | Marmara University Hospital, Radiation Oncology Department |
More Information
| Responsible Party: | Marmara University School of Medicine, Department of Radiation Oncology ( Assoc. Prof. Dr. Ufuk ABACIOGLU ) |
| Study ID Numbers: | MU-RO-2005-1 |
| Study First Received: | December 17, 2007 |
| Last Updated: | December 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00575887 History of Changes |
| Health Authority: | Turkey: Ministry of Health |
|
Temozolomide Brain Tumor, Recurrent Chemotherapy |
|
Glioblastoma Astrocytoma Disease Progression Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Temozolomide Recurrence Brain Neoplasms |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Antineoplastic Agents, Alkylating Glioma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Central Nervous System Neoplasms Brain Diseases Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Alkylating Agents Nervous System Neoplasms Neoplasms by Histologic Type |
Astrocytoma Nervous System Diseases Central Nervous System Diseases Temozolomide Pharmacologic Actions Neuroectodermal Tumors Brain Neoplasms Neoplasms Oligodendroglioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |
