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
- -
A Pilot Study of the Addition of Bevacizumab to VOIT Regimen for Relapsed/Refractory Pediatric Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2008-11-06
- Last Posted Date
- 2021-02-10
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Target Recruit Count
- 13
- Registration Number
- NCT00786669
- Locations
- 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)
- First Posted Date
- 2008-10-31
- Last Posted Date
- 2017-05-15
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 32
- Registration Number
- NCT00783393
ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- Interventions
- Drug: temozolomideDrug: veliparibGenetic: DNA methylation analysisGenetic: gene expression analysisGenetic: mutation analysisGenetic: proteomic profilingOther: high performance liquid chromatographyOther: immunoenzyme techniqueOther: laboratory biomarker analysisOther: mass spectrometryOther: pharmacogenomic studiesOther: pharmacological studyProcedure: adjuvant therapyRadiation: radiation therapy
- First Posted Date
- 2008-10-10
- Last Posted Date
- 2018-06-27
- Target Recruit Count
- 24
- Registration Number
- NCT00770471
- Locations
- 🇺🇸
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
🇺🇸Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
CT-322 in Combination With Radiation Therapy and Temozolomide to Treat Newly Diagnosed Glioblastoma Multiforme
- Conditions
- Interventions
- First Posted Date
- 2008-10-08
- Last Posted Date
- 2010-10-27
- Lead Sponsor
- Adnexus, A Bristol-Myers Squibb R&D Company
- Target Recruit Count
- 30
- Registration Number
- NCT00768911
- Locations
- 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸University of Kentucky Hospital, Lexington, Kentucky, United States
🇺🇸University of Chicago Medical Center, Chicago, Illinois, United States
Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
- First Posted Date
- 2008-09-29
- Last Posted Date
- 2014-11-14
- Lead Sponsor
- Isarna Therapeutics GmbH
- Target Recruit Count
- 27
- Registration Number
- NCT00761280
- Locations
- 🇦🇷
FLENI, Ciudad Autónoma de Buenos Aires, Argentina
🇺🇸NJ Neuroscience Institute; JFK Medical Center, Edison, New Jersey, United States
🇺🇸University of Rochester Medical Center, Rochester, New York, United States
MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma
- Conditions
- Interventions
- First Posted Date
- 2008-09-19
- Last Posted Date
- 2020-05-13
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 15
- Registration Number
- NCT00756106
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children
- Conditions
- Interventions
- First Posted Date
- 2008-09-09
- Last Posted Date
- 2018-07-20
- Lead Sponsor
- University Hospital, Bonn
- Target Recruit Count
- 174
- Registration Number
- NCT00749723
- Locations
- 🇩🇪
Universitätskinderklinik Freiburg, Freiburg, Germany
🇩🇪Universitätskinderklinik Göttingen, Göttingen, Germany
🇩🇪Universitätskinderklinik Heidelberg, Heidelberg, Germany
Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
- First Posted Date
- 2008-08-25
- Last Posted Date
- 2016-08-01
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 92
- Registration Number
- NCT00740636
- Locations
- 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan-Kettering Cancer Center at Commack, Commack, New York, United States
Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma
- Conditions
- Interventions
- First Posted Date
- 2008-08-14
- Last Posted Date
- 2018-11-09
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 18
- Registration Number
- NCT00734526
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- First Posted Date
- 2008-08-11
- Last Posted Date
- 2022-08-04
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 125
- Registration Number
- NCT00731731
- Locations
- 🇺🇸
Cancer Center of Kansas-Independence, Independence, Kansas, United States
🇺🇸Munson Medical Center, Traverse City, Michigan, United States
🇺🇸Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.