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
- -
Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2015-07-29
- Last Posted Date
- 2017-11-17
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 1
- Registration Number
- NCT02510950
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas
- First Posted Date
- 2015-07-23
- Last Posted Date
- 2020-07-28
- Lead Sponsor
- Santosh Kesari
- Target Recruit Count
- 2
- Registration Number
- NCT02507232
- Locations
- 🇺🇸
Providence Brain & Spine Institute, Portland, Oregon, United States
🇺🇸John Wayne Cancer Institute, Santa Monica, California, United States
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
- First Posted Date
- 2015-07-20
- Last Posted Date
- 2020-06-04
- Lead Sponsor
- NewLink Genetics Corporation
- Target Recruit Count
- 81
- Registration Number
- NCT02502708
- Locations
- 🇺🇸
Children's Heathcare of Atlanta, Atlanta, Georgia, United States
🇺🇸Augusta University, Augusta, Georgia, United States
🇺🇸Children's Hospital Colorado, Aurora, Colorado, United States
Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas
- Conditions
- Interventions
- First Posted Date
- 2015-07-14
- Last Posted Date
- 2015-07-14
- Lead Sponsor
- The First People's Hospital of Changzhou
- Target Recruit Count
- 120
- Registration Number
- NCT02496988
Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas
- Conditions
- Interventions
- First Posted Date
- 2015-07-10
- Last Posted Date
- 2015-07-10
- Lead Sponsor
- The First People's Hospital of Changzhou
- Target Recruit Count
- 80
- Registration Number
- NCT02494804
Temozolomide in Patients Affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer With MGMT Methylation
- First Posted Date
- 2015-06-23
- Last Posted Date
- 2018-11-13
- Target Recruit Count
- 6
- Registration Number
- NCT02477813
- Locations
- 🇮🇹
Oncologia Medica, Azienda ospedaliera universitaria di Ferrara, Ferrara, FE, Italy
🇮🇹Oncologia Medica AOU Policlinico di Modena, Modena, MO, Italy
🇮🇹U.O. Oncologia Medica, Faenza, RA, Italy
SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2015-05-28
- Last Posted Date
- 2024-03-01
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 66
- Registration Number
- NCT02455557
- Locations
- 🇺🇸
Dana-Farber Harvard Cancer Center, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy
- First Posted Date
- 2015-05-18
- Last Posted Date
- 2022-02-07
- Lead Sponsor
- Zofia Piotrowska
- Target Recruit Count
- 66
- Registration Number
- NCT02446704
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
- Conditions
- Interventions
- First Posted Date
- 2015-04-15
- Last Posted Date
- 2016-02-18
- Lead Sponsor
- Hebei Yanda Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT02416999
- Locations
- 🇨🇳
Hebei Yanda Hospital, Sanhe, Hebei, China
🇨🇳Beijing Tiantan Hospital, Beijing, Beijing, China
The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma
- Conditions
- Interventions
- First Posted Date
- 2015-04-10
- Last Posted Date
- 2020-02-07
- Lead Sponsor
- Tocagen Inc.
- Target Recruit Count
- 403
- Registration Number
- NCT02414165
- Locations
- 🇺🇸
Ohio State University, Columbus, Ohio, United States
🇺🇸Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
🇺🇸University of Miami, Miami, Florida, United States
Drug Development Updates
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