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
- -
Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma
- First Posted Date
- 2020-05-21
- Last Posted Date
- 2024-03-26
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Target Recruit Count
- 2
- Registration Number
- NCT04397679
- Locations
- 🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
- Conditions
- Metastatic ParagangliomaStage III Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8Advanced ParagangliomaUnresectable Adrenal Gland PheochromocytomaAdvanced Adrenal Gland PheochromocytomaStage IV Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8Metastatic Adrenal Gland PheochromocytomaUnresectable Paraganglioma
- Interventions
- First Posted Date
- 2020-05-20
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 76
- Registration Number
- NCT04394858
- Locations
- 🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States
🇺🇸Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
- First Posted Date
- 2020-05-14
- Last Posted Date
- 2020-06-09
- Target Recruit Count
- 10
- Registration Number
- NCT04388033
- Locations
- 🇨🇳
The Second Affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
🇨🇳Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Pilot Study of B7-H3 CAR-T in Treating Patients With Recurrent and Refractory Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2020-05-12
- Last Posted Date
- 2022-12-28
- Target Recruit Count
- 12
- Registration Number
- NCT04385173
- Locations
- 🇨🇳
the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)
- Conditions
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyBiological: DinutuximabProcedure: FDG-Positron Emission TomographyRadiation: Iobenguane I-123Drug: IrinotecanDrug: IsotretinoinProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanBiological: SargramostimDrug: Temozolomide
- First Posted Date
- 2020-05-12
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 41
- Registration Number
- NCT04385277
- Locations
- 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
NG101m Adjuvant Therapy in Glioblastoma Patients
- Conditions
- Interventions
- First Posted Date
- 2020-05-04
- Last Posted Date
- 2023-04-18
- Lead Sponsor
- NeuGATE Theranostics
- Target Recruit Count
- 52
- Registration Number
- NCT04373785
- Locations
- 🇺🇸
Yvonne Kew MD, PLLC, Houston, Texas, United States
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2020-04-07
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Valent Technologies, LLC
- Target Recruit Count
- 20
- Registration Number
- NCT04337177
- Locations
- 🇺🇸
Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, Indiana, United States
🇺🇸Sarah Cannon Research Institute, Pediatric Hematology & Oncology, Nashville, Tennessee, United States
🇺🇸Duke University Children's Hospital and Health Center, Durham, North Carolina, United States
A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2020-03-27
- Last Posted Date
- 2024-07-26
- Lead Sponsor
- Celgene
- Target Recruit Count
- 184
- Registration Number
- NCT04324840
- Locations
- 🇳🇱
Local Institution - 400, Rotterdam, Netherlands
🇳🇴Local Institution - 600, Oslo, Norway
🇳🇱Local Institution - 408, Leiden, Zuid-Holland, Netherlands
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
- Conditions
- Interventions
- First Posted Date
- 2020-03-20
- Last Posted Date
- 2020-03-20
- Lead Sponsor
- West China Hospital
- Target Recruit Count
- 250
- Registration Number
- NCT04316039
- Locations
- 🇨🇳
Xingchen Peng, Chengdu, Sichuan, China
Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma
- First Posted Date
- 2020-02-21
- Last Posted Date
- 2023-11-08
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Target Recruit Count
- 56
- Registration Number
- NCT04280848
- Locations
- 🇫🇷
Hôpital Saint-Louis, Paris, France
🇫🇷CHU Bordeaux, Bordeaux, France
🇫🇷CHU Besançon, Besançon, France
Drug Development Updates
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