DeepMed Research

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

Clinical Trials

Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: temozolomide
Procedure: adjuvant therapy
Radiation: radiation therapy

First Posted Date: 2003-01-27

Last Posted Date: 2014-02-21

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 170

Registration Number: NCT00028795

Locations: 🇺🇸
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Illinois Medical Center, Chicago, Illinois, United States

and more 226 locations

Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain

Phase 3

Terminated

Conditions: Melanoma (Skin)
Metastatic Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2012-09-24

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

Target Recruit Count: 23

Registration Number: NCT00020839

Locations: 🇬🇧
Addenbrooke's NHS Trust, Cambridge, England, United Kingdom
🇬🇧
Royal Marsden NHS Trust, London, England, United Kingdom
🇨🇭
UniversitaetsSpital, Zurich, Switzerland

and more 30 locations

Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-20

Lead Sponsor: Duke University

Registration Number: NCT00006474

Locations: 🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2018-06-27

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Registration Number: NCT00006025

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
🇺🇸
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 6 locations

Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma

Phase 2

Withdrawn

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2015-08-05

Lead Sponsor: NYU Langone Health

Registration Number: NCT00006263

Locations: 🇺🇸
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma

Phase 3

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2013-12-18

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 500

Registration Number: NCT00052455

Locations: 🇬🇧
Medical Research Council Clinical Trials Unit, London, England, United Kingdom

Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Phase 2

Terminated

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2012-06-06

Lead Sponsor: Northwestern University

Target Recruit Count: 29

Registration Number: NCT00004106

Locations: 🇺🇸
Yale Comprehensive Cancer Center at Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States

S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

Phase 2

Completed

Conditions: Gastrointestinal Stromal Tumor

Interventions: Drug: temozolomide

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-03

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 25

Registration Number: NCT00005597

Locations: 🇺🇸
MBCCOP - Gulf Coast, Mobile, Alabama, United States
🇺🇸
CCOP - Beaumont, Royal Oak, Michigan, United States
🇺🇸
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States

and more 103 locations

Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors
Neuroblastoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-20

Lead Sponsor: Duke University

Registration Number: NCT00005955

Locations: 🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Head and Neck Cancer
Kidney Cancer
Neuroblastoma
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-20

Lead Sponsor: Duke University

Target Recruit Count: 30

Registration Number: NCT00005952

Locations: 🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

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