Temozolomide

Generic Name: Temozolomide

Brand Names: Temodar, Temomedac, Temodal, Temozolomide Sun, Temozolomide Accord, Temozolomide Teva

Drug Type: Small Molecule

Chemical Formula: C_₆H_₆N_₆O_₂

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: -

Clinical Trials

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas

Phase 2

Completed

Conditions: Glioblastoma

Interventions: Drug: Lomustine
Drug: Depatuxizumab mafodotin
Drug: Temozolomide

First Posted Date: 2015-01-22

Last Posted Date: 2020-05-22

Lead Sponsor: AbbVie

Target Recruit Count: 266

Registration Number: NCT02343406

Locations: 🇫🇷
Hopital Pitie Salpetriere /ID# 145887, Paris, France
🇮🇹
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395, Milan, Italy
🇫🇷
CHU-Hopital Avicenne /ID# 137910, Bobigny, Ile-de-France, France

and more 99 locations

A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Phase 2

Active, not recruiting

Conditions: Glioblastoma Multiforme

Interventions: Drug: Temozolomide
Radiation: radiation therapy
Drug: Ascorbic Acid

First Posted Date: 2015-01-22

Last Posted Date: 2024-11-14

Lead Sponsor: Bryan Allen

Target Recruit Count: 90

Registration Number: NCT02344355

Locations: 🇺🇸
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)

Phase 2

Terminated

Conditions: Cancer of Brain and Nervous System

Interventions: Device: NovoTTF100A
Drug: Bevacizumab
Drug: Temozolomide

First Posted Date: 2015-01-22

Last Posted Date: 2022-11-03

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 13

Registration Number: NCT02343549

Locations: 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States

Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System

Phase 4

Completed

Conditions: Brain Neoplasms, Malignant, Primary

Interventions: Drug: Temozolomide

First Posted Date: 2015-01-21

Last Posted Date: 2015-04-02

Lead Sponsor: Monte Verde SA

Target Recruit Count: 24

Registration Number: NCT02343081

Locations: 🇦🇷
FLENI Instituto Clínico-Quirúrgico de Diagnóstico y Tratamiento, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
🇦🇷
FLENI Instituto de Rehabilitación y Educación Terapéutica, Escobar, Buenos Aires, Argentina

Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma

Phase 2

Terminated

Conditions: RECURRENT GLIOBLASTOMA

Interventions: Genetic: SGT-53
Drug: Temozolomide

First Posted Date: 2015-01-16

Last Posted Date: 2021-03-03

Lead Sponsor: SynerGene Therapeutics, Inc.

Target Recruit Count: 1

Registration Number: NCT02340156

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇨🇳
China Medical University Hospital, Taichung, Taiwan

Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase 1

Completed

Conditions: Adult Brain Glioblastoma
Adult Giant Cell Glioblastoma
Adult Gliosarcoma

Interventions: Drug: Dimethyl Fumarate
Drug: Temozolomide
Radiation: Radiation Therapy

First Posted Date: 2015-01-13

Last Posted Date: 2019-06-28

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 12

Registration Number: NCT02337426

Locations: 🇺🇸
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse

Phase 2

Completed

Conditions: Glioblastoma

Interventions: Drug: Temozolomide

First Posted Date: 2015-01-05

Last Posted Date: 2023-07-24

Lead Sponsor: Beijing Sanbo Brain Hospital

Target Recruit Count: 204

Registration Number: NCT02330991

Image-derived Prediction of Response to Chemo-radiation in Glioblastoma

Terminated

Conditions: Glioblastoma

Interventions: Radiation: Radiotherapy
Drug: Temozolomide

First Posted Date: 2015-01-01

Last Posted Date: 2017-10-12

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 16

Registration Number: NCT02329795

Locations: 🇩🇰
Department of Oncology, Section for Radiotherapy, Rigshospitalet, Copenhagen, Denmark

A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma

Phase 1

Completed

Conditions: Glioblastoma

Interventions: Drug: BBI608
Drug: Temozolomide

First Posted Date: 2014-12-12

Last Posted Date: 2023-11-15

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 34

Registration Number: NCT02315534

Locations: 🇺🇸
Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
🇨🇦
University of Calgary, Calgary, Alberta, Canada
🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

Phase 1

Completed

Conditions: Gliosarcoma
Supratentorial Glioblastoma

Interventions: Biological: Ipilimumab
Biological: Nivolumab
Other: Laboratory Biomarker Analysis
Drug: Temozolomide

First Posted Date: 2014-12-09

Last Posted Date: 2023-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 32

Registration Number: NCT02311920

Locations: 🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 8 locations

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