TEMODAR Capsules for oral administration contain temozolomide, an imidazotetrazine derivative.
TEMODAR (temozolomide) Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, ie, patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine.
This indication is based on the response rate in the indicated population. No results are available from randomized controlled trials in recurrent anaplastic astrocytoma that demonstrate a clinical benefit resulting from treatment, such as improvement in disease-related symptoms, delayed disease progression, or improved survival.
Published Studies Related to Temodar (Temozolomide)
Prolonged survival with valproic acid use in the EORTC/NCIC temozolomide trial for glioblastoma. [2011.09.20]
OBJECTIVE: This analysis was performed to assess whether antiepileptic drugs (AEDs) modulate the effectiveness of temozolomide radiochemotherapy in patients with newly diagnosed glioblastoma... CONCLUSIONS: VPA may be preferred over an EIAED in patients with glioblastoma who require an AED during TMZ-based chemoradiotherapy. Future studies are needed to determine whether VPA increases TMZ bioavailability or acts as an inhibitor of histone deacetylases and thereby sensitizes for radiochemotherapy in vivo.
Radiotherapy followed by adjuvant temozolomide with or without neoadjuvant ACNU-CDDP chemotherapy in newly diagnosed glioblastomas: a prospective randomized controlled multicenter phase III trial. [2011.07]
A prospective randomized controlled multicenter phase III trial was conducted to evaluate the effects of neoadjuvant chemotherapy with nimustine (ACNU)-cisplatin (CDDP) when used in conjunction with radiotherapy plus adjuvant temozolomide in patients with newly diagnosed glioblastoma...
Central nervous system failure in melanoma patients: results of a randomised, multicentre phase 3 study of temozolomide- and dacarbazine- based regimens. [2011.06.07]
BACKGROUND: This study compared the central nervous system (CNS) metastasis incidence between a temozolomide- and a dacarbazine-based regimen in untreated stage IV melanoma patients... CONCLUSION: The incidence of CNS failures in metastatic melanoma was not significantly reduced and the clinical course was not modified substituting a dacarbazine-based regimen with a temozolomide-based regimen. Patients who developed CNS metastases did not have a worse prognosis than patients progressing in other sites and should not be excluded from new investigational studies.
A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. [2010.11]
External beam radiation therapy (XRT) with concomitant temozolomide and 6 cycles of adjuvant temozolomide (5/28-day schedule) improves survival in patients with newly diagnosed glioblastoma compared with XRT alone...
Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. [2010.10.20]
PURPOSE: Temozolomide (TMZ) is an alkylating agent licensed for treatment of high-grade glioma (HGG). No prospective comparison with nitrosourea-based chemotherapy exists. We report, to our knowledge, the first randomized trial of procarbazine, lomustine, and vincristine (PCV) versus TMZ in chemotherapy-naive patients with recurrent HGG... CONCLUSION: Although TMZ (both arms combined) did not show a clear benefit compared with PCV, comparison of the TMZ schedules demonstrated that the 21-day schedule was inferior to the 5-day schedule in this setting. This challenges the current understanding of increasing TMZ dose-intensity by prolonged scheduling.
Clinical Trials Related to Temodar (Temozolomide)
Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM) [Active, not recruiting]
The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at
the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and
then the combination of Avastin and Temodar, after radiation is complete, on malignant brain
About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose
of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation.
Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed
dose of Avastin intravenously (through the vein) every 14 days. They will also be given a
higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.
Sarasar and Temodar for Glioblastoma Multiforme Patients [Active, not recruiting]
The goal of this clinical research study is to find the highest safe dose of the new drug
Sarasar (lonafarnib) that can be given together with Temodar (temozolomide) in a continuous
daily dosing regimen to patients with brain tumors. The second goal is to learn if these
drugs given in combination can shrink or slow the growth of brain tumors.
Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors [Completed]
The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma
who have recently undergone surgery and who have not been treated with radiation therapy or
chemotherapy. This is called a phase II study. The purpose of the phase II study is to
determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of
glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva.
There is no "placebo" drug.
A Phase I/II Study of TPI 287 - Temozolomide Combination in Melanoma [Recruiting]
The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI
287 that can be given in combination with Temodar (temozolomide) to patients with metastatic
The goal of the Phase II portion of this study is to learn if TPI 287, given in combination
with temozolomide, can control metastatic melanoma. The safety of this combination will
also be studied.
Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma [Completed]
To define role of O6-Benzylguanine (BG) in restoring Temodar (temozolomide) sensitivity in
patients with Temodar-resistant malignant glioma.
To further define toxicity of combo therapy using Temodar + BG.
Reports of Suspected Temodar (Temozolomide) Side Effects
Platelet Count Decreased (17),
Disease Progression (8),
Neoplasm Progression (7),
Fall (7), more >>
Page last updated: 2011-12-09