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 of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2017-07-21
- Last Posted Date
- 2022-05-31
- Target Recruit Count
- 71
- Registration Number
- NCT03224104
- Locations
- 🇨🇭
UniversitaetsSpital Zurich, Zürich, Switzerland
🇦🇹Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken, Vienna, Austria
🇫🇷Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone, Marseille, France
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
- First Posted Date
- 2017-07-11
- Last Posted Date
- 2023-11-08
- Lead Sponsor
- Northwell Health
- Target Recruit Count
- 67
- Registration Number
- NCT03213002
- Locations
- 🇺🇸
Lenox Hill Brain Tumor Center, New York, New York, United States
A Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Extrapancreatic Neuroendocrine Tumor
- Conditions
- Interventions
- First Posted Date
- 2017-06-29
- Last Posted Date
- 2017-06-29
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Target Recruit Count
- 60
- Registration Number
- NCT03204032
- Locations
- 🇨🇳
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Pembrolizumab and Standard Therapy in Treating Patients with Glioblastoma
- First Posted Date
- 2017-06-23
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 52
- Registration Number
- NCT03197506
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery
- Conditions
- Interventions
- First Posted Date
- 2017-06-19
- Last Posted Date
- 2023-10-11
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 12
- Registration Number
- NCT03190967
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Study of Chemoimmunotherapy for High-Risk Neuroblastoma
- Conditions
- Interventions
- First Posted Date
- 2017-06-16
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 48
- Registration Number
- NCT03189706
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
- Conditions
- Interventions
- First Posted Date
- 2017-06-08
- Last Posted Date
- 2024-03-21
- Lead Sponsor
- NRG Oncology
- Target Recruit Count
- 148
- Registration Number
- NCT03180502
- Locations
- 🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸Central Maryland Radiation Oncology in Howard County, Columbia, Maryland, United States
🇺🇸Maryland Proton Treatment Center, Baltimore, Maryland, United States
Atezolizumab in Combination With Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2017-06-02
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 80
- Registration Number
- NCT03174197
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma
- Conditions
- Interventions
- First Posted Date
- 2017-05-30
- Last Posted Date
- 2019-10-01
- Lead Sponsor
- University of Alabama at Birmingham
- Target Recruit Count
- 5
- Registration Number
- NCT03168919
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2017-05-12
- Last Posted Date
- 2022-05-31
- Lead Sponsor
- BeiGene USA, Inc.
- Target Recruit Count
- 116
- Registration Number
- NCT03150862
- Locations
- 🇺🇸
UCLA Neuro-Oncology, Los Angeles, California, United States
🇺🇸Sarah Cannon Research Institute at Health One, Denver, Colorado, United States
🇺🇸Washington University, Saint Louis, Missouri, United States
Drug Development Updates
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