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
- -
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2018-07-16
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- University of Oklahoma
- Target Recruit Count
- 27
- Registration Number
- NCT03587038
- Locations
- 🇺🇸
Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations
- Conditions
- Interventions
- First Posted Date
- 2018-07-10
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 38
- Registration Number
- NCT03581292
- Locations
- 🇺🇸
Henry Ford Health Saint John Hospital, Detroit, Michigan, United States
🇺🇸Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸USA Health Strada Patient Care Center, Mobile, Alabama, United States
GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas
- Conditions
- Interventions
- First Posted Date
- 2018-07-03
- Last Posted Date
- 2023-06-29
- Target Recruit Count
- 36
- Registration Number
- NCT03576612
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Temozolomide (TMZ) in Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)
- Conditions
- Interventions
- First Posted Date
- 2018-06-14
- Last Posted Date
- 2024-11-04
- Lead Sponsor
- Adam Burgoyne, MD, PhD
- Target Recruit Count
- 23
- Registration Number
- NCT03556384
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸Oregon Health & Science University, Portland, Oregon, United States
🇺🇸UC San Diego Moores Cancer Center, La Jolla, California, United States
M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers
- Conditions
- Interventions
- First Posted Date
- 2018-06-13
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 80
- Registration Number
- NCT03554473
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
SGT-53 in Children With Recurrent or Progressive CNS Malignancies
- Conditions
- Interventions
- First Posted Date
- 2018-06-13
- Last Posted Date
- 2022-02-08
- Lead Sponsor
- SynerGene Therapeutics, Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT03554707
- Locations
- 🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma
- Conditions
- Interventions
- First Posted Date
- 2018-05-18
- Last Posted Date
- 2024-11-15
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 40
- Registration Number
- NCT03528642
- Locations
- 🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2018-05-02
- Last Posted Date
- 2024-08-15
- Lead Sponsor
- Case Comprehensive Cancer Center
- Target Recruit Count
- 60
- Registration Number
- NCT03514069
- Locations
- 🇺🇸
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide
- First Posted Date
- 2018-04-12
- Last Posted Date
- 2023-04-26
- Lead Sponsor
- Gradalis, Inc.
- Target Recruit Count
- 32
- Registration Number
- NCT03495921
- Locations
- 🇺🇸
Texas Oncology - Pediatrics, Dallas, Texas, United States
🇺🇸Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸Dana-Farber/Boston Children's Cancer and Blood Disorders, Boston, Massachusetts, United States
Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System
- Conditions
- Interventions
- First Posted Date
- 2018-04-12
- Last Posted Date
- 2024-05-01
- Target Recruit Count
- 208
- Registration Number
- NCT03495960
- Locations
- 🇫🇮
Tampere University Hospital, Tampere, Finland
🇮🇱Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
🇮🇹Ospedale C.e G. Mazzoni, Ascoli Piceno, Italy
Drug Development Updates
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