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
- -
Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
- Conditions
- Interventions
- First Posted Date
- 2014-12-04
- Last Posted Date
- 2024-05-14
- Lead Sponsor
- University of Birmingham
- Target Recruit Count
- 225
- Registration Number
- NCT02308527
- Locations
- 🇦🇹
St Anna Children's Hospital and CCRI/Studies and Statistics, Vienna, Austria
🇩🇰University Hospital Rigshospitalet, Copenhagen, Denmark
🇮🇹Ospedale Pediatrico Bambino Gseu, Rome, Italy
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
- Conditions
- Interventions
- First Posted Date
- 2014-11-10
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 56
- Registration Number
- NCT02287428
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas
- First Posted Date
- 2014-10-13
- Last Posted Date
- 2018-07-17
- Lead Sponsor
- Huashan Hospital
- Target Recruit Count
- 67
- Registration Number
- NCT02263105
- Locations
- 🇨🇳
Huashan Hospital, Shanghai, Shanghai, China
Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- First Posted Date
- 2014-08-28
- Last Posted Date
- 2014-12-23
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 19
- Registration Number
- NCT02227901
- Locations
- 🇺🇸
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
- First Posted Date
- 2014-08-06
- Last Posted Date
- 2021-01-12
- Lead Sponsor
- Grupo Español de Investigación en Neurooncología
- Target Recruit Count
- 166
- Registration Number
- NCT02209948
- Locations
- 🇪🇸
Consorcio Hospitalario Provincial de Castellón, Castelló, Valencia, Spain
🇪🇸Hospital Universitari Germans Trias i Pujol/ICO Badalona, Badalona, Barcelona, Spain
🇪🇸Institut Català d'Oncologia L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain
A Prospective Cohort to Study the Effect of Temozolomide on IDH Mutational Low Grade Gliomas
- First Posted Date
- 2014-08-05
- Last Posted Date
- 2019-02-21
- Lead Sponsor
- Huashan Hospital
- Target Recruit Count
- 54
- Registration Number
- NCT02209428
- Locations
- 🇨🇳
Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
- First Posted Date
- 2014-07-17
- Last Posted Date
- 2023-12-01
- Lead Sponsor
- Katy Peters, MD, PhD
- Target Recruit Count
- 24
- Registration Number
- NCT02193347
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2014-07-01
- Last Posted Date
- 2024-11-29
- Lead Sponsor
- NRG Oncology
- Target Recruit Count
- 624
- Registration Number
- NCT02179086
- Locations
- 🇺🇸
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
🇺🇸Saint Joseph Hospital - Orange, Orange, California, United States
🇺🇸UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Subventricular Zone (SVZ) and Temozolomide in Glioblastoma Multiforme
- Conditions
- Interventions
- First Posted Date
- 2014-06-27
- Last Posted Date
- 2024-06-07
- Target Recruit Count
- 60
- Registration Number
- NCT02177578
- Locations
- 🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸The SKCCC at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸Suburban Hospital, Bethesda, Maryland, United States
Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma
- First Posted Date
- 2014-06-20
- Last Posted Date
- 2023-11-24
- Lead Sponsor
- University of Nebraska
- Target Recruit Count
- 4
- Registration Number
- NCT02168270
- Locations
- 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
Drug Development Updates
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