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
- -
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- Interventions
- First Posted Date
- 2014-06-02
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 447
- Registration Number
- NCT02152982
- Locations
- 🇺🇸
Mercy Health - Perrysburg Hospital, Perrysburg, Ohio, United States
🇺🇸University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸Katmai Oncology Group, Anchorage, Alaska, United States
Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies
- Conditions
- Interventions
- First Posted Date
- 2014-04-17
- Last Posted Date
- 2021-03-26
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 40
- Registration Number
- NCT02116777
- Locations
- 🇺🇸
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
🇺🇸UCSF Medical Center-Mission Bay, San Francisco, California, United States
🇺🇸Children's Hospital Colorado, Aurora, Colorado, United States
Preoperative Chemoradiation for Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2014-03-19
- Last Posted Date
- 2015-11-10
- Lead Sponsor
- Tampa General Hospital
- Target Recruit Count
- 1
- Registration Number
- NCT02092038
- Locations
- 🇺🇸
Tampa General Hospital, Tampa, Florida, United States
Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM
- First Posted Date
- 2014-03-12
- Last Posted Date
- 2024-04-19
- Target Recruit Count
- 8
- Registration Number
- NCT02085304
- Locations
- 🇺🇸
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Combo of Abraxane, TMZ, Bevacizumab in Metastatic Melanoma With Brain Metastases
- Conditions
- Interventions
- First Posted Date
- 2014-02-19
- Last Posted Date
- 2016-04-21
- Lead Sponsor
- University of Arizona
- Registration Number
- NCT02065466
- Locations
- 🇺🇸
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
🇺🇸University of Arizona Cancer Center, Tucson, Arizona, United States
Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
- Conditions
- Interventions
- First Posted Date
- 2014-02-03
- Last Posted Date
- 2024-03-27
- Lead Sponsor
- NewLink Genetics Corporation
- Target Recruit Count
- 160
- Registration Number
- NCT02052648
- Locations
- 🇺🇸
Augusta University, Augusta, Georgia, United States
🇺🇸University Cancer and Blood Center, Athens, Georgia, United States
🇺🇸UC Irvine Chao Family Comprehensive Cancer Center, Orange, California, United States
PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid Tumors
- First Posted Date
- 2014-01-30
- Last Posted Date
- 2022-09-26
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Target Recruit Count
- 44
- Registration Number
- NCT02049593
- Locations
- 🇺🇸
Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2014-01-27
- Last Posted Date
- 2021-06-16
- Target Recruit Count
- 14
- Registration Number
- NCT02046187
- Locations
- 🇺🇸
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma
- Conditions
- Interventions
- First Posted Date
- 2014-01-23
- Last Posted Date
- 2021-01-12
- Target Recruit Count
- 34
- Registration Number
- NCT02044120
- Locations
- 🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸Seattle's Children Cancer Center, Seattle, Washington, United States
🇬🇧University College London Hospital, London, United Kingdom
Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2014-01-08
- Last Posted Date
- 2017-08-18
- Lead Sponsor
- King Fahad Medical City
- Target Recruit Count
- 36
- Registration Number
- NCT02029573
- Locations
- 🇸🇦
King Fahad Medical City, Riyadh, Saudi Arabia
Drug Development Updates
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