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Temodar (Temozolomide) - Summary

 
 



TEMODAR SUMMARY

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.


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NEWS HIGHLIGHTS

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.

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Clinical Trials Related to Temodar (Temozolomide)

A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma [Recruiting]
The goals of this Phase II study of TEMODAR in the treatment of adult patients with supratentorial low grade glioma are to determine the efficacy (complete response, partial response, and time to tumor progression) and the safety of TEMODAR in this patient population. Since the majority of these tumors are mixed histologies (oligoastrocytoma), for the primary analysis, patients with mixed histologies are considered. It is important however, to assess the efficacy of this agent in this patient population and patients with all low grade histologies will be allowed to participate in the study.

Sarasar and Temodar for Glioblastoma Multiforme Patients [Active, not recruiting]
Primary Objectives:

1. To determine the maximum tolerated dose Sarasar (SCH66336, lonafarnib) when combined with Temodar (temozolomide) in an alternating week schedule.

2. To describe the toxicities of the Sarasar and Temodar combination treatment using this dosing schedule.

3. To evaluate response as measured by 6-month progression-free survival and objective tumor response.

Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma [Recruiting]
This is a single site, open label, non-randomized phase II study. Patients with radiographically proven recurrent, intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), Gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified). Patients will be treated with temozolomide orally, in a fasting state, at a dose of 150mg/m˛ daily for seven consecutive days of every other week. The intent is to enroll 40 patients with grade 4 and 20 patients with grade 3 tumors.

Ph I 5-Day Temo + O6-BG in Treatment of Pts w Recurrent / Progressive GBM [Active, not recruiting]
Primary objectives To determine maxi tolerated dose of TemodarŽ in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w TemodarŽ in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine NeulastaŽ-supported MTD defined as the MTD of TemodarŽ in combo with O6-BG administered for 5 days while receiving NeulastaŽ once per treatment cycle between days 7 & 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of TemodarŽ in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM

Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma [Active, not recruiting]
This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized (1: 1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Patients assigned to the sequential treatment group will receive temozolomide until progression of disease is documented and then receive ATN-224 as a single agent until documentation of progression of disease using the last tumor assessment on temozolomide therapy as the baseline assessment.

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Reports of Suspected Temodar (Temozolomide) Side Effects

Death (18)Platelet Count Decreased (17)Chills (8)Disease Progression (8)Vomiting (8)Nausea (8)Pancytopenia (8)Neoplasm Progression (7)Constipation (7)Fall (7)more >>


Page last updated: 2011-12-09

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