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
- -
INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
- Conditions
- Interventions
- First Posted Date
- 2018-04-09
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Inovio Pharmaceuticals
- Target Recruit Count
- 52
- Registration Number
- NCT03491683
- Locations
- 🇺🇸
University of Pennsylvania Health System: Penn Medicine, Philadelphia, Pennsylvania, United States
🇺🇸Rutgers University - Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸Baylor College of Medicine, Houston, Texas, United States
Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)
- Conditions
- Interventions
- First Posted Date
- 2018-03-29
- Last Posted Date
- 2019-08-14
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Registration Number
- NCT03480867
- Locations
- 🇨🇦
McGill University Health Centre-Cedars Cancer Centre, Montréal, Québec, Canada, Canada
Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2018-03-26
- Last Posted Date
- 2024-04-05
- Target Recruit Count
- 30
- Registration Number
- NCT03477110
- Locations
- 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Hydroxy-urea and Temozolomide in Patients With a Recurrent Malignant Brain Tumor (Glioblastoma)
- First Posted Date
- 2018-03-13
- Last Posted Date
- 2020-10-08
- Lead Sponsor
- M.E. van Linde
- Target Recruit Count
- 54
- Registration Number
- NCT03463733
- Locations
- 🇳🇱
VU University Medical Center, Amsterdam, Noord-Holland, Netherlands
Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2018-02-08
- Last Posted Date
- 2023-07-19
- Target Recruit Count
- 21
- Registration Number
- NCT03426891
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer
- First Posted Date
- 2018-02-07
- Last Posted Date
- 2023-11-08
- Lead Sponsor
- Saint John's Cancer Institute
- Target Recruit Count
- 49
- Registration Number
- NCT03425292
- Locations
- 🇺🇸
Saint John's Cancer Institute, Santa Monica, California, United States
UNITE Study: Understanding New Interventions With GBM ThErapy
- First Posted Date
- 2018-02-05
- Last Posted Date
- 2021-04-14
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 40
- Registration Number
- NCT03419403
- Locations
- 🇩🇪
Universitatsklinikum Tubingen /ID# 169965, Tuebingen, Germany
🇺🇸Levine Cancer Ins, Carolina Me /ID# 171271, Charlotte, North Carolina, United States
🇳🇱Vrije Universiteit Medisch Centrum /ID# 170152, Amsterdam, Netherlands
A Study of Apatinib Combined With Temozolomide in Patients Witn Advanced Melanoma
- First Posted Date
- 2018-02-05
- Last Posted Date
- 2018-02-05
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Target Recruit Count
- 30
- Registration Number
- NCT03422445
- Locations
- 🇨🇳
Beijing Cancer Hospital, Beijing, China
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2018-01-03
- Last Posted Date
- 2018-01-03
- Lead Sponsor
- Biotech Pharmaceutical Co., Ltd.
- Target Recruit Count
- 39
- Registration Number
- NCT03388372
- Locations
- 🇨🇳
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
🇨🇳Guangdong Brain Hospital, Guangdong, China
🇨🇳Shenzhen People's Hospital, Shenzhen, China
CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas
- Conditions
- Interventions
- First Posted Date
- 2018-01-02
- Last Posted Date
- 2021-02-26
- Target Recruit Count
- 112
- Registration Number
- NCT03387592
- Locations
- 🇮🇹
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, FC, Italy
🇮🇹Azienda Ospedaliera-Universitaria di Modena, Modena, MO, Italy
🇮🇹Ospedale Civile degli Infermi, Faenza, RA, Italy
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