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 ...

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

Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

Phase 3

Terminated

Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer AJCC v7
Metastatic Malignant Neoplasm in the Brain

Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Erlotinib Hydrochloride
Radiation: Stereotactic Radiosurgery
Drug: Temozolomide

First Posted Date: 2004-11-09

Last Posted Date: 2018-03-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 126

Registration Number: NCT00096265

Locations: 🇨🇦
McGill University Department of Oncology, Montreal, Quebec, Canada
🇺🇸
Parkview Hospital Randallia, Fort Wayne, Indiana, United States
🇺🇸
Integrated Community Oncology Network-Flager Cancer Center, Saint Augustine, Florida, United States

and more 80 locations

N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

Phase 1

Completed

Conditions: Diarrhea
Drug/Agent Toxicity by Tissue/Organ
Neuroblastoma

First Posted Date: 2004-10-08

Last Posted Date: 2010-10-15

Lead Sponsor: Children's Hospital Los Angeles

Target Recruit Count: 30

Registration Number: NCT00093353

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States

and more 10 locations

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

Phase 3

Completed

Conditions: Melanoma

Interventions: Drug: Temozolomide
Drug: Dacarbazine

First Posted Date: 2004-09-14

Last Posted Date: 2017-06-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 859

Registration Number: NCT00091572

Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2004-08-26

Last Posted Date: 2012-03-06

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

Target Recruit Count: 29

Registration Number: NCT00003304

Locations: 🇳🇱
St. Elisabeth Ziekenhuis, Tilburg, Netherlands
🇫🇮
Turku University Central Hospital, Turku, Finland
🇫🇷
Institut Bergonie, Bordeaux, France

and more 34 locations

Chemotherapy in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2004-08-04

Last Posted Date: 2012-08-09

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Target Recruit Count: 32

Registration Number: NCT00003708

Locations: 🇺🇸
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
🇺🇸
San Antonio Cancer Institute, San Antonio, Texas, United States

Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2004-07-12

Last Posted Date: 2017-07-27

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

Target Recruit Count: 110

Registration Number: NCT00086879

Locations: 🇫🇷
Centre Antoine Lacassagne, Nice, France
🇳🇱
Medisch Centrum Haaglanden, 's-Gravenhage, Netherlands
🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium

and more 7 locations

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

Phase 1

Completed

Conditions: Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma

Interventions: Drug: cilengitide
Drug: temozolomide
Radiation: radiation therapy
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2004-06-11

Last Posted Date: 2016-02-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 112

Registration Number: NCT00085254

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 5 locations

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

Phase 2

Completed

Conditions: Central Nervous System Tumor, Pediatric

Interventions: Biological: filgrastim
Drug: cisplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: leucovorin calcium
Drug: methotrexate
Drug: temozolomide
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy
Drug: Dactinomycin

First Posted Date: 2004-06-11

Last Posted Date: 2015-12-24

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 25

Registration Number: NCT00084838

Locations: 🇺🇸
Stanford Cancer Center, Stanford, California, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, United States

and more 9 locations

Temozolomide in Treating Women With Advanced Breast Cancer

Phase 2

Conditions: Breast Cancer

First Posted Date: 2004-06-08

Last Posted Date: 2013-09-20

Lead Sponsor: The Christie NHS Foundation Trust

Registration Number: NCT00005054

Locations: 🇬🇧
Christie Hospital N.H.S. Trust, Manchester, England, United Kingdom

Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2004-05-26

Last Posted Date: 2018-06-26

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 44

Registration Number: NCT00006358

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Simmons Cancer Center - Dallas, Dallas, Texas, United States
🇺🇸
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

and more 8 locations

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