Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Central Nervous System Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

O(6)-benzylguanine

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Objectives of study are to define role of BG in restoring Temodar sensitivity in patients with Temodar-resistant malignant glioma and to further define the toxicity of combination therapy using Temodar + BG. 2 separate strata accrued independently of each other: Stratum 1-patients with glioblastoma multiforme (GBM). Stratum 2-patients with anaplastic glioma (AG).

BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24 hours. Temodar 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle.

Temodar and O6-Benzylguanine (BG)

David A. Reardon, MD

Objectives:

To define role of O6-Benzylguanine (BG) in restoring Temodar (temozolomide) sensitivity in patients with Temodar-resistant malignant glioma.

To further define toxicity of combo therapy using Temodar + BG.

2 separate strata accrued independently of each other: Stratum 1-patients with Glioblastoma Multiforme (GBM). Stratum 2-patients with Anaplastic Glioma \[anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed (AA and AO)\] .

BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24hrs. Temozolomide 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle.

Temodar has been well tolerated by both adults and children with most common toxicity being mild myelosuppression. Other, less likely, potential toxicities include nausea and vomiting, constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy, hepatotoxicity, anorexia, fatigue and hyperglycemia. Hypersensitivity reactions have not yet been noted with Temodar. As in the case with many anti-cancer drugs, Temodar may be carcinogenic. BG toxicities include agitation, lethargy, nausea, vomiting, rapid heart rate, elevated liver functions, \& leukemia; but, not with BG as single agent. Transient lymphopenia has been seen with BG as single agent.

Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma

Phase II Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Temodar-Resistant Malignant Glioma

Keryx / AOI Pharmaceuticals, Inc.

National Institutes of Health (NIH)

Duke University

fatma sedeek

Mostafa Mostafa

Hosameldeen Metwalli

Noha Attia

The aim of this study is to evaluate the role of automatic segmentation of cerebral gliomas in multi-sequence MR images using state-of-the-art methods for automatic segmentation and internal classification of brain tumors in correlation with operative findings

Gliomas are the most common primary brain tumors and are classified by their histopathological appearances using the World Health Organization (WHO) system into low-grade glioma (LGG) (grades I and II) and high-grade glioma (grade III anaplastic glioma and grade IV glioblastoma.

Gliomas, particularly high-grade, exhibit irregular growth patterns infiltrating the surrounding brain and thus showing irregular boundaries that may not be clear on conventional magnetic resonance images (MRI) MR images are visually inspected by radiologists, however, visual assessment is subjective, time consuming and prone to variability due to inter-rater differences. Accurate delineation of tumor boundaries as well as assessment of tumor volume are essential for treatment planning and monitoring treatment response . However, accurate delineation of the boundaries of glioma using subjective visual assessment is often difficult due to tumor heterogeneity and complexity, overlapping signal intensity with surrounding tissues and uneven tumor growth into nearby structures .

Compared to tumor volumetry, the routine visual evaluation of tumor size is based upon simple linear measurements of the gross tumor volume. These bi-dimensional measurements are often performed on a single MRI slice without volumetric measurements. These linear measurements are user-dependent and prone to errors due to increased measurement variability, especially in irregularly shaped lesions Computer-based fully-automatic tumor segmentation methods present a possible solution to these issues. The process is based upon information extraction from structural brain MRI images using a probabilistic tissue model to define the clear tumor boundaries using different MRI pulse sequences. These methods could accurately and rapidly identify glioma from surrounding normal brain tissue, and perform tumor volumetry, while eliminating intra-observer and inter-observer variability Internal changes within glioma, such as enhancement pattern and degeneration are crucial for identification of glioma grade, planning of treatment, monitoring of disease progression and evaluating the efficacy of therapy. In the process of automatic glioma segmentation, different parts of the glioma are characterized as solid (active) tumor, necrosis and peri-tumoral edema .

Automatic segmentation methods utilize artificial intelligence and machine learning techniques for extraction of information from multi-sequence MRI including, basically, T1W, Gadolinium enhanced T1W, T2W and FLAIR sequences .

Appropriate assessment of the extent of tumor resection plays an important role in the prognosis of glioma, since maximizing the extent of resection influences survival in these patients. Complete resection of enhancing tumor, defined as the removal of the final 1-2% of the tumor, seems to provide the most benefit in terms of patient's survival . Automatic segmentation could lead to better diagnosis and proper treatment planning through accurate tumor localization and classification .

Automatic Segmentation MRI Cerebral Glioma

The Added Value of Automatic Segmentation of Cerebral Gliomas in Multi-Sequence Magnetic Resonance Imaging (MRI)

The aim of this study is to evaluate the role of automatic segmentation of cerebral gliomas in multi-sequence MR images using state-of-the-art methods for automatic segmentation and internal classification of brain tumors in correlation with operative findings.

Assiut University

assuit egypt

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma	NCT00613093	Glioblastoma Mu... Anaplastic Glio...	Temodar and O6-...	18 Years -	Duke University
Automatic Segmentation MRI Cerebral Glioma	NCT04674579	Cerebral Gliobl...	MRI	-	Assiut University

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