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
- -
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases
- Conditions
- Interventions
- First Posted Date
- 2016-01-13
- Last Posted Date
- 2017-06-06
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Target Recruit Count
- 65
- Registration Number
- NCT02654106
- Locations
- 🇨🇳
Chinese Academy of Medical Sciences, Beijing, Beijing, China
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
- Conditions
- Interventions
- First Posted Date
- 2015-12-01
- Last Posted Date
- 2023-03-28
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 560
- Registration Number
- NCT02617589
- Locations
- 🇺🇸
Johns Hopkins University School Of Medicine, Baltimore, Maryland, United States
🇺🇸Local Institution - 0090, Chattanooga, Tennessee, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-11-16
- Last Posted Date
- 2019-03-28
- Lead Sponsor
- Guangzhou Medical University
- Target Recruit Count
- 426
- Registration Number
- NCT02605811
- Locations
- 🇨🇳
The first affiliated hospital of Guangzhou MC, Guangzhou, Guangdong, China
Phase II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma
- Conditions
- Interventions
- First Posted Date
- 2015-11-06
- Last Posted Date
- 2015-11-06
- Lead Sponsor
- M.D. Anderson Cancer Center
- Registration Number
- NCT02599090
Prospective Pilot Trial to Assess a Multimodal Molecular Targeted Therapy in Children, Adolescent and Young Adults With Relapsed or Refractory High-grade Pineoblastoma
- Conditions
- Interventions
- First Posted Date
- 2015-11-04
- Last Posted Date
- 2021-08-05
- Lead Sponsor
- University of Regensburg
- Target Recruit Count
- 4
- Registration Number
- NCT02596828
- Locations
- 🇩🇪
University Hospital of Regensburg, Regensburg, Germany
Cisplatin, Carboplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients With Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery
- First Posted Date
- 2015-11-03
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- Target Recruit Count
- 67
- Registration Number
- NCT02595424
- Locations
- 🇺🇸
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
🇺🇸Grant Medical Center, Columbus, Ohio, United States
🇺🇸Doctors Hospital, Columbus, Ohio, United States
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
- Conditions
- Interventions
- First Posted Date
- 2015-10-29
- Last Posted Date
- 2020-09-03
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 53
- Registration Number
- NCT02590263
- Locations
- 🇯🇵
University of Tsukuba Hospital /ID# 140433, Tsukuba-shi, Ibaraki, Japan
🇯🇵Osaka University Hospital /ID# 140438, Suita-shi, Osaka, Japan
🇯🇵Iwate Medical University Hospital /ID# 149145, Shiwa-gun, Iwate, Japan
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
- Conditions
- Interventions
- First Posted Date
- 2015-10-09
- Last Posted Date
- 2023-05-11
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 691
- Registration Number
- NCT02573324
- Locations
- 🇺🇸
Piedmont Hospital /ID# 145892, Atlanta, Georgia, United States
🇺🇸Emory Midtown Infectious Disease Clinic /ID# 144015, Atlanta, Georgia, United States
🇺🇸University of Pennsylvania Medical Center - Shadyside /ID# 144159, Pittsburgh, Pennsylvania, United States
Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2015-08-21
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 4
- Registration Number
- NCT02530502
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
- Conditions
- Interventions
- First Posted Date
- 2015-07-29
- Last Posted Date
- 2022-12-22
- Lead Sponsor
- Gradalis, Inc.
- Target Recruit Count
- 22
- Registration Number
- NCT02511132
- Locations
- 🇺🇸
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
🇺🇸Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸Nicklaus Children's Hospital (Miami Children's Health System), Miami, Florida, United States
Drug Development Updates
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