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
- -
Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2017-05-12
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- BeiGene
- Target Recruit Count
- 139
- Registration Number
- NCT03150810
- Locations
- 🇺🇸
Start Midwest, Grand Rapids, Michigan, United States
🇺🇸Washington University in St Louis, Saint Louis, Missouri, United States
🇺🇸Montefiore Medical Park At Eastchester Einstein Campus, Bronx, New York, United States
Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2017-05-04
- Last Posted Date
- 2024-05-16
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 36
- Registration Number
- NCT03139916
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts general Hospital, Boston, Massachusetts, United States
PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma
- Conditions
- Interventions
- First Posted Date
- 2017-05-03
- Last Posted Date
- 2021-01-05
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 16
- Registration Number
- NCT03139331
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸UCSF Benioff Children's Hospital, Oakland, Oakland, California, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2017-05-03
- Last Posted Date
- 2024-02-13
- Lead Sponsor
- Emory University
- Target Recruit Count
- 34
- Registration Number
- NCT03137888
- Locations
- 🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
🇺🇸Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Study of Letrozole in Recurrent Gliomas
- Conditions
- Interventions
- First Posted Date
- 2017-04-20
- Last Posted Date
- 2023-12-13
- Lead Sponsor
- University of Cincinnati
- Target Recruit Count
- 39
- Registration Number
- NCT03122197
- Locations
- 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2017-04-18
- Last Posted Date
- 2022-12-13
- Lead Sponsor
- Brown University
- Target Recruit Count
- 12
- Registration Number
- NCT03119064
- Locations
- 🇺🇸
Rhode Island Hospital, Providence, Rhode Island, United States
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
- Conditions
- Interventions
- First Posted Date
- 2017-01-12
- Last Posted Date
- 2024-07-25
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 90
- Registration Number
- NCT03018288
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma
- Conditions
- Interventions
- First Posted Date
- 2017-01-05
- Last Posted Date
- 2024-05-13
- Lead Sponsor
- University of Chicago
- Target Recruit Count
- 60
- Registration Number
- NCT03011671
- Locations
- 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
Phase II/III Trial of CCRT With or Without JP001 for Newly Diagnosed GBM
- Conditions
- Interventions
- First Posted Date
- 2017-01-02
- Last Posted Date
- 2021-05-11
- Lead Sponsor
- Johnpro Biotech, Inc.
- Target Recruit Count
- 288
- Registration Number
- NCT03008148
- Locations
- 🇨🇳
Taipei Veterans General Hospital, Taipei City, Taiwan
🇨🇳Tri-Service General Hospital, Taipei City, Taiwan
INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
- Conditions
- Interventions
- First Posted Date
- 2016-11-30
- Last Posted Date
- 2024-10-17
- Lead Sponsor
- Patrick Wen, MD
- Target Recruit Count
- 460
- Registration Number
- NCT02977780
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Drug Development Updates
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