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
- -
BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations
- First Posted Date
- 2019-04-16
- Last Posted Date
- 2024-12-16
- Target Recruit Count
- 67
- Registration Number
- NCT03914742
- Locations
- 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸University of Virginia, Charlottesville, Virginia, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Pan Tumor Rollover Study
- Conditions
- Interventions
- Drug: NivolumabDrug: LeucovorinDrug: Nivolumab + RelatlimabDrug: RegorafinibDrug: CapecitabineDrug: PemetrexedDrug: EnzalutamideDrug: SunitinibDrug: PembrolizumabDrug: RelatlimabDrug: TemozolomideDrug: RucaparibDrug: IpilimumabDrug: DaratumumabDrug: FluorouracilDrug: CabozantinibDrug: TrametinibDrug: BevacizumabDrug: Oxaliplatin
- First Posted Date
- 2019-04-02
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1500
- Registration Number
- NCT03899155
- Locations
- 🇧🇷
Local Institution - 0260, Belo Horizonte, Minas Gerais, Brazil
🇨🇳Harbin Medical University - Cancer Hospital, Harbin, Heilongjiang, China
🇨🇳Local Institution - 0172, Changsha, Hunan, China
Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer
- First Posted Date
- 2019-03-19
- Last Posted Date
- 2019-12-12
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Registration Number
- NCT03879811
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
- First Posted Date
- 2019-03-19
- Last Posted Date
- 2024-10-15
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 23
- Registration Number
- NCT03880019
- Locations
- 🇺🇸
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
🇺🇸Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
A Study to Evaluate the Safety of LAM561 Added to Standard of Care in Newly-diagnosed Glioblastoma Patients
- First Posted Date
- 2019-03-07
- Last Posted Date
- 2023-02-21
- Lead Sponsor
- Laminar Pharmaceuticals
- Target Recruit Count
- 18
- Registration Number
- NCT03867123
- Locations
- 🇪🇸
Hospital Duran i Reynals, Institut Català d'Oncologia, L'Hospitalet De Llobregat, Cataluña, Spain
🇪🇸Institut Catala d'Oncologia, Hospital Germans Trias I Pujol, Badalona, Cataluña, Spain
🇪🇸Hospital Universitari de Girona Dr. Josep Trueta, Institut Català d'Oncologia, Girona, Cataluña, Spain
NIVOLUMAB Plus IPILIMUMAB and TEMOZOLOMIDE in Microsatellite Stable, MGMT Silenced Metastatic Colorectal Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-02-06
- Last Posted Date
- 2022-04-04
- Target Recruit Count
- 135
- Registration Number
- NCT03832621
- Locations
- 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, MI, Italy
Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy
- Conditions
- Interventions
- First Posted Date
- 2019-02-05
- Last Posted Date
- 2024-02-13
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Target Recruit Count
- 74
- Registration Number
- NCT03830918
- Locations
- 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
- First Posted Date
- 2019-01-08
- Last Posted Date
- 2021-04-09
- Lead Sponsor
- University of Rochester
- Registration Number
- NCT03796507
- Locations
- 🇺🇸
University of Rochester Medical Center, Rochester, New York, United States
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
- Conditions
- Interventions
- First Posted Date
- 2019-01-07
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 95
- Registration Number
- NCT03794349
- Locations
- 🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸Yale University, New Haven, Connecticut, United States
🇺🇸Children's National Medical Center, Washington, District of Columbia, United States
Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2018-12-20
- Last Posted Date
- 2024-08-20
- Lead Sponsor
- MediciNova
- Target Recruit Count
- 50
- Registration Number
- NCT03782415
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Drug Development Updates
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