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

Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme

Phase 2

Terminated

Conditions: Glioblastoma
Glioblastoma Multiforme

Interventions: Drug: Disulfiram
Dietary Supplement: Copper gluconate
Drug: Temozolomide

First Posted Date: 2017-12-06

Last Posted Date: 2024-10-03

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 15

Registration Number: NCT03363659

Locations: 🇺🇸
Aurora Health Care, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, United States

Irinotecan and Temozolomide for Ewing Sarcoma

Phase 2

Recruiting

Conditions: Ewing Sarcoma

Interventions: Drug: Vincristine
Drug: Temozolomide

First Posted Date: 2017-12-02

Last Posted Date: 2022-11-01

Lead Sponsor: Peking University People's Hospital

Target Recruit Count: 60

Registration Number: NCT03359005

Locations: 🇨🇳
Peking University People's Hospital, Beijing, Beijing, China

Two Chemotherapy Regimens Plus or Minus Bevacizumab

Phase 2

Active, not recruiting

Conditions: Pancreatic Cancer

Interventions: Drug: LV5FU2
Drug: Capecitabine
Drug: Streptozocin
Drug: Temozolomide
Drug: Bevacizumab

First Posted Date: 2017-11-22

Last Posted Date: 2024-05-08

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 140

Registration Number: NCT03351296

Locations: 🇫🇷
Gustave Roussy, Villejuif, Val De Marne, France
🇫🇷
CHU de Caen, Caen, Calvados, France
🇫🇷
ICM Val d'Aurelle, Montpellier, Hérault, France

and more 16 locations

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

Phase 3

Completed

Conditions: Newly Diagnosed Glioblastoma

Interventions: Drug: Marizomib
Drug: Temozolomide
Radiation: radiotherapy

First Posted Date: 2017-11-17

Last Posted Date: 2024-07-12

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

Target Recruit Count: 749

Registration Number: NCT03345095

Locations: 🇺🇸
University of California, San Francisco, California, United States
🇨🇦
Saint John Regional Hospital, Saint John, New Brunswick, Canada
🇨🇭
University Hospital of Geneva, Geneva, Switzerland

and more 78 locations

Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma

Phase 1

Completed

Conditions: Recurrent Lymphoma
Recurrent Malignant Solid Neoplasm
Recurrent Primary Central Nervous System Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Primary Central Nervous System Neoplasm

Interventions: Drug: Irinotecan
Drug: Pevonedistat
Drug: Temozolomide

First Posted Date: 2017-10-26

Last Posted Date: 2024-10-22

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 30

Registration Number: NCT03323034

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States

and more 17 locations

Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme

Phase 2

Completed

Conditions: Glioblastoma Multiforme

Interventions: Radiation: Ultrafractionated brain irradiation
Drug: Temozolomide

First Posted Date: 2017-10-16

Last Posted Date: 2017-10-17

Lead Sponsor: Central Hospital, Nancy, France

Target Recruit Count: 46

Registration Number: NCT03310372

5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme

Early Phase 1

Completed

Conditions: Glioblastoma Multiforme

Interventions: Drug: Temozolomide

First Posted Date: 2017-09-25

Last Posted Date: 2021-11-19

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 3

Registration Number: NCT03291990

Locations: 🇺🇸
Sibley Hospital, Washington, District of Columbia, United States
🇺🇸
Suburban Hospital, Washington, District of Columbia, United States
🇺🇸
SKCCC at Johns Hopkins (East Baltimore), Baltimore, Maryland, United States

Quality of Life and Neurocognitive Functioning

Not Applicable

Completed

Conditions: Glioma

Interventions: Drug: Temozolomide
Other: QoL, neurocognitive and psycholpathological assessment

First Posted Date: 2017-08-22

Last Posted Date: 2022-01-11

Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Target Recruit Count: 26

Registration Number: NCT03257618

Locations: 🇫🇷
Institut regional du Cancer - Val d Aurelle, Montpellier, France

Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

Phase 1

Terminated

Conditions: Glioblastoma

Interventions: Drug: Cannabis
Drug: Temozolomide
Radiation: Radiation Therapy

First Posted Date: 2017-08-11

Last Posted Date: 2019-08-13

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 1

Registration Number: NCT03246113

Locations: 🇺🇸
New York State Psychiatric Institute, New York, New York, United States
🇺🇸
Columbia University Medical Center- Department of Radiation Oncology, New York, New York, United States

NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma

Phase 1

Completed

Conditions: Glioblastoma, Adult

Interventions: Device: NovoTTF-200A
Drug: Temozolomide
Radiation: 3D conformal or intensity modulated radiation therapy (IMRT)

First Posted Date: 2017-07-28

Last Posted Date: 2024-11-18

Lead Sponsor: Hackensack Meridian Health

Target Recruit Count: 12

Registration Number: NCT03232424

Locations: 🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

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