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

Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma

Phase 2

Terminated

Conditions: Brain Tumors
Central Nervous System Tumors
Leptomeningeal Metastases

Interventions: Drug: temozolomide

First Posted Date: 2003-01-27

Last Posted Date: 2013-05-14

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 12

Registration Number: NCT00005812

Locations: 🇺🇸
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2013-04-04

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00005637

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: temozolomide

First Posted Date: 2003-01-27

Last Posted Date: 2013-07-11

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 7

Registration Number: NCT00022711

Locations: 🇺🇸
Kimball Medical Center, Lakewood, New Jersey, United States
🇺🇸
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly, New Jersey, United States
🇺🇸
South Jersey Regional Cancer Center, Millville, New Jersey, United States

and more 14 locations

Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

Phase 2

Conditions: Sarcoma

First Posted Date: 2003-01-27

Last Posted Date: 2014-01-06

Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Registration Number: NCT00033709

Locations: 🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States

Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas

Phase 3

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: TMZ 200mg/m2
Drug: BCNU 80mg/m2
Radiation: radiation therapy
Drug: BCNU 200mg/m2
Drug: BCNU 150mg/m2
Drug: TMZ 150mg/m2 six 8-week cycles
Drug: TMZ 150mg/m2 six 6-week cycles
Drug: CCNU

First Posted Date: 2003-01-27

Last Posted Date: 2019-09-12

Lead Sponsor: Radiation Therapy Oncology Group

Target Recruit Count: 230

Registration Number: NCT00004259

Locations: 🇺🇸
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States
🇺🇸
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States
🇺🇸
Mason District Hospital, Havana, Illinois, United States

and more 89 locations

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor

Phase 2

Withdrawn

Conditions: Retinoblastoma
Brain and Central Nervous System Tumors
Neuroblastoma
Sarcoma

First Posted Date: 2003-01-27

Last Posted Date: 2015-12-03

Lead Sponsor: NYU Langone Health

Registration Number: NCT00003273

Locations: 🇺🇸
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
🇺🇸
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
🇺🇸
Maine Children's Cancer Program, Scarborough, Maine, United States

and more 16 locations

Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2014-08-22

Lead Sponsor: Duke University

Registration Number: NCT00005951

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

Temozolomide in Treating Patients With Progressive Low-Grade Glioma

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2014-07-09

Lead Sponsor: Duke University

Target Recruit Count: 100

Registration Number: NCT00003466

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

Phase 2

Completed

Conditions: Melanoma (Skin)

First Posted Date: 2003-01-27

Last Posted Date: 2013-03-26

Lead Sponsor: Saint Francis Hospital

Registration Number: NCT00014092

Locations: 🇺🇸
John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, California, United States
🇺🇸
Saint Francis Memorial Hospital, San Francisco, California, United States
🇺🇸
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States

Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Neuroblastoma
Unspecified Childhood Solid Tumor, Protocol Specific
Extragonadal Germ Cell Tumor
Sarcoma
Kidney Cancer
Liver Cancer
Ovarian Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2015-04-29

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT00020150

Locations: 🇺🇸
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

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