Temozolomide

Generic Name
Temozolomide
Brand Names
Temodar, Temomedac, Temodal, Temozolomide Sun, Temozolomide Accord, Temozolomide Teva
Drug Type
Small Molecule
Chemical Formula
C6H6N6O2
CAS Number
85622-93-1
Unique Ingredient Identifier
YF1K15M17Y
Background

Refractory anaplastic astrocytoma (WHO grade III) and Glioblastoma multiforme (WHO grade IV) are primary malignant brain tumours with poor prognosis and limited treatment options. Despite considerable genetic heterogeneity, these tumours often have impaired DNA repair systems, rendering them initially sensitive to alkylating agents, although they invariably develop resistance to these agents over time. Temozolomide is an imidazotetrazine prodrug that is stable at acidic pH but undergoes spontaneous nonenzymatic hydrolysis at neutral or slightly basic pH; these properties allow for both oral and intravenous administration. Following initial hydrolysis, further reactions liberate a highly reactive methyl diazonium cation capable of methylating various residues on adenosine and guanine bases leading to DNA lesions and eventual apoptosis. Temozomolide as an adjunct to radiotherapy followed by maintenance dosing remains the standard of care for both Glioblastoma and refractory anaplastic astrocytoma.

Temozolomide was granted FDA approval on August 11, 1999, as an oral capsule and subsequently on February 27, 2009, as an intravenous injection. It is currently marketed under the trademark TEMODAR® by Merck.

Indication

Temozolomide is indicated in adult patients for the treatment of newly diagnosed glioblastoma concomitantly with radiotherapy and for use as maintenance treatment thereafter. It is also indicated for the treatment of refractory anaplastic astrocytoma in adult patients or adjuvant therapy for adults with newly diagnosed anaplastic astrocytoma.

Associated Conditions
Advanced Melanoma, High Grade Glioma: Glioblastoma (GBM), Primary Central Nervous System Lymphoma, Refractory Ewing Sarcoma, Refractory Neuroblastoma, Soft Tissue Sarcoma, Advanced Neuroendocrine tumor, Newly diagnosed Anaplastic Astrocytoma (AA), Refractory Anaplastic astrocytoma, Refractory, advanced Mycosis fungoides, Refractory, advanced Sezary Syndrome
Associated Therapies
-
Clinical Trials
Related News

TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM

First Posted Date
2018-12-19
Last Posted Date
2018-12-20
Lead Sponsor
NovoCure Ltd.
Target Recruit Count
10
Registration Number
NCT03780569
Locations
🇮🇱

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

HFSRT With Concurrent TMZ for Large BMs

First Posted Date
2018-12-19
Last Posted Date
2019-07-23
Lead Sponsor
Chinese Academy of Medical Sciences
Target Recruit Count
224
Registration Number
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Locations
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Chinese Academy of Medical Sciences, Beijing, Beijing, China

18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy

First Posted Date
2018-12-19
Last Posted Date
2023-12-12
Lead Sponsor
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Target Recruit Count
43
Registration Number
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Locations
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Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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Mayo Clinic in Rochester, Rochester, Minnesota, United States

A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1

First Posted Date
2018-12-14
Last Posted Date
2024-04-22
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Target Recruit Count
260
Registration Number
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Locations
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New York University Medical Oncology Associates, New York, New York, United States

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University of Kentucky Markey Cancer Center, Lexington, Kentucky, United States

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Messino Cancer Centers, Asheville, North Carolina, United States

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Trial in Low Grade Glioma Patients: Wait or Treat

First Posted Date
2018-12-04
Last Posted Date
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Target Recruit Count
19
Registration Number
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Locations
🇬🇧

Clatterbridge Centre for Oncology NHS Trust - Clatterbridge NHS -Wirral, Wirral, United Kingdom

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Prince of Wales Hospital, Randwick - Sydney, New South Wales, Australia

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CHRU de Lille, Lille, France

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BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

First Posted Date
2018-11-21
Last Posted Date
2024-08-19
Lead Sponsor
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Target Recruit Count
78
Registration Number
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Locations
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Duke University Medical Center, Durham, North Carolina, United States

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Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

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Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, Hackensack, New Jersey, United States

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Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma

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Last Posted Date
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Target Recruit Count
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Registration Number
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Locations
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TMZ Plus Apatinib in Newly Diagnosed High-grade Glioma：RCT

Phase 2
Conditions
Glioma
Interventions
Drug: apatinib
Drug: Temozolomide
First Posted Date
2018-11-14
Last Posted Date
2019-07-23
Lead Sponsor
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Target Recruit Count
211
Registration Number
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Locations
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the Second Hospital of Hebei Medical University, Shijiazhuang, China

Nivolumab and Temozolomide in Treating Patients with Recurrent or Refractory Small-Cell Lung Cancer or Advanced Neuroendocrine Cancer

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2018-11-02
Last Posted Date
2024-11-04
Lead Sponsor
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55
Registration Number
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Locations
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Ohio State University Comprehensive Cancer Center-COHORT 1, Columbus, Ohio, United States

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Ohio State University Comprehensive Cancer Center-COHORT 2, Columbus, Ohio, United States

Phase 1 Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

First Posted Date
2018-10-23
Last Posted Date
2024-12-12
Lead Sponsor
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Target Recruit Count
321
Registration Number
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Locations
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Precision NextGen Oncology and Research, Beverly Hills, California, United States

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University of California, San Francisco (UCSF), San Francisco, California, United States

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Children's Hospital of Philadelphia- Center for Childhood Cancer Research, Philadelphia, Pennsylvania, United States

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