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
- -
Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma
- Conditions
- Interventions
- First Posted Date
- 2020-02-12
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Target Recruit Count
- 41
- Registration Number
- NCT04267146
- Locations
- 🇫🇷
CHU Angers, Angers, France
🇫🇷Centre Oscar Lambret, Lille, France
🇫🇷Centre Léon Bérard, Lyon, France
LAM561 With RT and TMZ for Adults With Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2020-01-31
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- Laminar Pharmaceuticals
- Target Recruit Count
- 140
- Registration Number
- NCT04250922
- Locations
- 🇪🇸
Hospital Clinic, Barcelona, Spain
🇪🇸Hospital Clínico San Carlos, Madrid, Spain
🇪🇸Hospital Vall d'Hebron, Barcelona, Spain
9-ING-41 in Pediatric Patients with Refractory Malignancies.
- Conditions
- Interventions
- First Posted Date
- 2020-01-23
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- Actuate Therapeutics Inc.
- Target Recruit Count
- 68
- Registration Number
- NCT04239092
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸Children's Hospital Colorado, Aurora, Colorado, United States
🇺🇸University of Chicago, Chicago, Illinois, United States
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
- Conditions
- Interventions
- First Posted Date
- 2020-01-23
- Last Posted Date
- 2024-06-21
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 117
- Registration Number
- NCT04238819
- Locations
- 🇦🇺
Perth Children's Hospital, Perth, Western Australia, Australia
🇯🇵National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
🇧🇪UZ Gent, Gent, Oost-Vlaanderen, Belgium
Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
- First Posted Date
- 2020-01-02
- Last Posted Date
- 2024-10-11
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 11
- Registration Number
- NCT04216329
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
- Conditions
- Interventions
- First Posted Date
- 2019-12-26
- Last Posted Date
- 2024-02-16
- Lead Sponsor
- Nationwide Children's Hospital
- Target Recruit Count
- 31
- Registration Number
- NCT04211675
- Locations
- 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
- Conditions
- Stage III Uterine Corpus Leiomyosarcoma AJCC v8Stage IVA Uterine Corpus Leiomyosarcoma AJCC v8Unresectable LeiomyosarcomaStage IIIC Uterine Corpus Leiomyosarcoma AJCC v8Stage IV Uterine Corpus Leiomyosarcoma AJCC v8Metastatic LeiomyosarcomaUnresectable Soft Tissue SarcomaMetastatic Soft Tissue SarcomaStage IIIA Uterine Corpus Leiomyosarcoma AJCC v8Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8
- Interventions
- First Posted Date
- 2019-12-16
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 72
- Registration Number
- NCT04200443
- Locations
- 🇺🇸
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
- Conditions
- Interventions
- First Posted Date
- 2019-12-13
- Last Posted Date
- 2024-10-15
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 20
- Registration Number
- NCT04199026
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
- Conditions
- Interventions
- First Posted Date
- 2019-12-11
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- University of Sydney
- Target Recruit Count
- 103
- Registration Number
- NCT04195139
- Locations
- 🇦🇺
Gosford Hospital, Gosford, New South Wales, Australia
🇦🇺Icon Cancer Centre, South Brisbane, Queensland, Australia
🇦🇺Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
- First Posted Date
- 2019-11-15
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- BeiGene
- Target Recruit Count
- 300
- Registration Number
- NCT04164199
- Locations
- 🇨🇳
Henan Cancer Hospital, Zhengzhou, Henan, China
🇨🇳The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
🇨🇳The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang, Jiangxi, China
Drug Development Updates
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