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

Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme

Phase 2

Terminated

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2005-10-13

Last Posted Date: 2018-06-27

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 15

Registration Number: NCT00238277

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

Phase 2

Completed

Conditions: Glioblastoma
Gliomas

Interventions: Drug: Temozolomide

First Posted Date: 2005-09-20

Last Posted Date: 2018-03-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 127

Registration Number: NCT00200161

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center at Commack, Commack, New York, United States
🇺🇸
Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Continuous Temozolomide in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer
Soft Tissue Sarcoma

Interventions: Drug: Temozolomide

First Posted Date: 2005-09-19

Last Posted Date: 2007-11-14

Lead Sponsor: University of Washington

Target Recruit Count: 35

Registration Number: NCT00194766

Locations: 🇺🇸
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States

Radiation Therapy or Temozolomide in Treating Patients With Gliomas

Phase 3

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Radiation: radiation therapy
Drug: temozolomide

First Posted Date: 2005-09-16

Last Posted Date: 2016-10-12

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 709

Registration Number: NCT00182819

Locations: 🇨🇦
Edmond Odette Cancer Centre at Sunnybrook, Toronto, Ontario, Canada
🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada

and more 86 locations

Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors

Phase 2

Completed

Conditions: Glioblastoma Multiforme
Gliosarcoma

Interventions: Drug: Tarceva
Drug: Temodar
Procedure: Radiation Therapy

First Posted Date: 2005-09-16

Last Posted Date: 2017-09-05

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 66

Registration Number: NCT00187486

Locations: 🇺🇸
UCSF Department of Neurological Surgery, San Francisco, California, United States

Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

Phase 2

Completed

Conditions: Neuroendocrine Tumor

First Posted Date: 2005-09-14

Last Posted Date: 2009-04-28

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 32

Registration Number: NCT00165230

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconness Medical Center, Boston, Massachusetts, United States

Prolonged Daily Temozolomide for Low-Grade Glioma

Phase 2

Completed

Conditions: Glioma
Astrocytoma
Oligodendroglioma

First Posted Date: 2005-09-14

Last Posted Date: 2009-11-01

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 46

Registration Number: NCT00165360

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

Phase 2

Completed

Conditions: Neuroendocrine Tumors

First Posted Date: 2005-08-30

Last Posted Date: 2013-04-09

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 34

Registration Number: NCT00137774

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Insitute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors
Unspecified Childhood Solid Tumor, Protocol Specific

Interventions: Drug: irinotecan hydrochloride
Drug: temozolomide
Drug: vincristine sulfate

First Posted Date: 2005-08-30

Last Posted Date: 2023-10-02

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 42

Registration Number: NCT00138216

Locations: 🇺🇸
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
🇨🇦
Hopital Sainte Justine, Montreal, Quebec, Canada

and more 15 locations

Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2005-08-10

Last Posted Date: 2012-09-24

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 20

Registration Number: NCT00128700

Locations: 🇳🇱
Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, Netherlands
🇩🇪
Klinikum der Universitaet Regensburg, Regensburg, Germany
🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium

and more 2 locations

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