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
- -
Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- First Posted Date
- 2006-04-21
- Last Posted Date
- 2013-04-10
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 56
- Registration Number
- NCT00316849
- Locations
- 🇺🇸
Altru Cancer Center, Grand Forks, North Dakota, United States
🇺🇸Medical Oncology and Hematology Associates, Des Moines, Iowa, United States
🇺🇸Iowa Lutheran Hospital, Des Moines, Iowa, United States
Temozolomide in Treating Patients With Low-Grade Glioma
- First Posted Date
- 2006-04-12
- Last Posted Date
- 2019-02-07
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 120
- Registration Number
- NCT00313729
- Locations
- 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
- Conditions
- First Posted Date
- 2006-04-06
- Last Posted Date
- 2006-09-08
- Lead Sponsor
- Heidelberg University
- Target Recruit Count
- 46
- Registration Number
- NCT00311857
- Locations
- 🇩🇪
University of Heidelberg, Heidelberg, Baden-Württemberg, Germany
Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
- Conditions
- Interventions
- First Posted Date
- 2006-04-06
- Last Posted Date
- 2014-09-30
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 59
- Registration Number
- NCT00311584
- Locations
- 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
- First Posted Date
- 2006-03-22
- Last Posted Date
- 2018-03-05
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 118
- Registration Number
- NCT00305864
- Locations
- 🇺🇸
Memorial Hospital, Carthage, Illinois, United States
🇺🇸Mason District Hospital, Havana, Illinois, United States
🇺🇸University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors
- First Posted Date
- 2006-03-17
- Last Posted Date
- 2012-03-15
- Target Recruit Count
- 26
- Registration Number
- NCT00303940
- Locations
- 🇺🇸
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office, Bethesda, Maryland, United States
Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors
- Conditions
- Interventions
- First Posted Date
- 2006-03-13
- Last Posted Date
- 2016-08-18
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 43
- Registration Number
- NCT00302159
- Locations
- 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States
🇺🇸National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
🇺🇸University of Pennsylvania, Philadelphia, Pennsylvania, United States
Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma
- Conditions
- Interventions
- First Posted Date
- 2006-03-10
- Last Posted Date
- 2019-06-04
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 20
- Registration Number
- NCT00301067
- Locations
- 🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
- Conditions
- First Posted Date
- 2006-01-30
- Last Posted Date
- 2007-10-31
- Lead Sponsor
- Kentuckiana Cancer Institute
- Target Recruit Count
- 40
- Registration Number
- NCT00283543
- Locations
- 🇺🇸
Kentuckiana Cancer Institute, Louisville, Kentucky, United States
Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
- Conditions
- First Posted Date
- 2006-01-13
- Last Posted Date
- 2013-09-17
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- Registration Number
- NCT00276679
- Locations
- 🇬🇧
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
🇬🇧Royal London Hospital, London, England, United Kingdom
🇬🇧Children's Hospital - Sheffield, Sheffield, England, United Kingdom
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.