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
- -
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
- Conditions
- Interventions
- First Posted Date
- 2009-06-08
- Last Posted Date
- 2019-04-23
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Target Recruit Count
- 15
- Registration Number
- NCT00915694
- Locations
- 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM
- Conditions
- Interventions
- First Posted Date
- 2009-05-20
- Last Posted Date
- 2021-03-24
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 70
- Registration Number
- NCT00905060
- Locations
- 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸University of California, San Francisco, San Francisco, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
Treatment Strategy for Low-grade Gliomas
- Conditions
- Interventions
- First Posted Date
- 2009-05-12
- Last Posted Date
- 2014-08-05
- Lead Sponsor
- Sun Yat-sen University
- Target Recruit Count
- 500
- Registration Number
- NCT00897377
- Locations
- 🇨🇳
Sun Yat-sen University, Guangzhou, Guangdong, China
Methoxyamine and Temozolomide in Treating Patients With Advanced Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2009-05-04
- Last Posted Date
- 2019-02-22
- Lead Sponsor
- Case Comprehensive Cancer Center
- Target Recruit Count
- 66
- Registration Number
- NCT00892385
- Locations
- 🇺🇸
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas
- Conditions
- Interventions
- First Posted Date
- 2009-04-30
- Last Posted Date
- 2018-05-02
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Target Recruit Count
- 27
- Registration Number
- NCT00890786
- Locations
- 🇺🇸
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
🇺🇸Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2009-04-21
- Last Posted Date
- 2019-07-24
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 637
- Registration Number
- NCT00884741
- Locations
- 🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States
🇺🇸Grant Medical Center, Columbus, Ohio, United States
🇺🇸The Mark H Zangmeister Center, Columbus, Ohio, United States
Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
- Conditions
- Interventions
- First Posted Date
- 2009-04-07
- Last Posted Date
- 2023-07-03
- Lead Sponsor
- Johns Hopkins All Children's Hospital
- Target Recruit Count
- 26
- Registration Number
- NCT00876993
- Locations
- 🇺🇸
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2009-04-03
- Last Posted Date
- 2009-08-26
- Lead Sponsor
- Institut Curie
- Target Recruit Count
- 100
- Registration Number
- NCT00875355
- Locations
- 🇫🇷
Institut Curie Hopital, Paris, France
Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- Interventions
- First Posted Date
- 2009-03-26
- Last Posted Date
- 2020-02-13
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 217
- Registration Number
- NCT00869401
- Locations
- 🇺🇸
Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford, Connecticut, United States
🇺🇸Illinois CancerCare - Canton, Canton, Illinois, United States
🇺🇸Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Capecitabine and Temozolomide for Neuroendocrine Cancers
- First Posted Date
- 2009-03-25
- Last Posted Date
- 2016-07-25
- Lead Sponsor
- Columbia University
- Target Recruit Count
- 41
- Registration Number
- NCT00869050
- Locations
- 🇺🇸
Columbia University Medical Center, New York, New York, United States
Drug Development Updates
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