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
- -
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
- Conditions
- Interventions
- First Posted Date
- 2006-11-22
- Last Posted Date
- 2020-08-06
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 72
- Registration Number
- NCT00402116
- Locations
- 🇺🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, San Francisco, California, United States
Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer
- Conditions
- First Posted Date
- 2006-11-17
- Last Posted Date
- 2011-07-08
- Lead Sponsor
- The Cleveland Clinic
- Target Recruit Count
- 25
- Registration Number
- NCT00401180
- Locations
- 🇺🇸
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
- First Posted Date
- 2006-11-17
- Last Posted Date
- 2018-09-18
- Lead Sponsor
- The Cleveland Clinic
- Target Recruit Count
- 29
- Registration Number
- NCT00400816
- Locations
- 🇺🇸
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- First Posted Date
- 2006-11-01
- Last Posted Date
- 2007-05-30
- Lead Sponsor
- Novacea
- Target Recruit Count
- 60
- Registration Number
- NCT00394628
- Locations
- 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸Henry Ford Health Systems, Detroit, Michigan, United States
🇺🇸Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors
- Conditions
- Interventions
- Drug: carboplatinDrug: temozolomideDrug: cisplatinDrug: thiotepaDrug: cyclophosphamideDrug: vincristine sulfateDrug: etoposideProcedure: autologous bone marrow transplantationDrug: methotrexateProcedure: autologous hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy
- First Posted Date
- 2006-10-26
- Last Posted Date
- 2013-12-18
- Lead Sponsor
- Children's Hospital Los Angeles
- Target Recruit Count
- 120
- Registration Number
- NCT00392886
- Locations
- 🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇦🇺Princess Margaret Hospital for Children, Perth, Western Australia, Australia
🇺🇸Children's Hospital of Orange County, Orange, California, United States
The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)
- Conditions
- Interventions
- First Posted Date
- 2006-10-25
- Last Posted Date
- 2017-06-07
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 120
- Registration Number
- NCT00392171
Gossypol (AT-101) and Temozolomide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- First Posted Date
- 2006-10-19
- Last Posted Date
- 2012-05-03
- Target Recruit Count
- 50
- Registration Number
- NCT00390403
- Locations
- 🇺🇸
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
🇺🇸H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
🇺🇸Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme
- Conditions
- First Posted Date
- 2006-10-13
- Last Posted Date
- 2023-08-04
- Lead Sponsor
- NCIC Clinical Trials Group
- Target Recruit Count
- 32
- Registration Number
- NCT00387400
- Locations
- 🇨🇦
McGill University - Dept. Oncology, Montreal, Quebec, Canada
🇨🇦Tom Baker Cancer Centre, Calgary, Alberta, Canada
🇨🇦Cross Cancer Institute, Edmonton, Alberta, Canada
PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs
- Conditions
- Interventions
- First Posted Date
- 2006-10-11
- Last Posted Date
- 2013-10-21
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 19
- Registration Number
- NCT00385853
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC
- Conditions
Drug Development Updates
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