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)
Randomized phase II trial of chemoradiotherapy followed by either dose-dense or metronomic temozolomide for newly diagnosed glioblastoma. [2009.08.10]
PURPOSE: Alternative dosing schedules of temozolomide may improve survival in patients with newly diagnosed glioblastoma (GBM) by increasing the therapeutic index, overcoming common mechanisms of temozolomide resistance, or both. The goal of this randomized phase II study was to evaluate two different temozolomide regimens in the adjuvant treatment of newly diagnosed GBM... CONCLUSION: Both dose-dense and metronomic temozolomide regimens were well tolerated with modest toxicity. The dose-dense regimen appears promising, with 1-year survival of 80%.
Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. [2009.05]
BACKGROUND: In 2004, a randomised phase III trial by the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) reported improved median and 2-year survival for patients with glioblastoma treated with concomitant and adjuvant temozolomide and radiotherapy. We report the final results with a median follow-up of more than 5 years... INTERPRETATION: Benefits of adjuvant temozolomide with radiotherapy lasted throughout 5 years of follow-up. A few patients in favourable prognostic categories survive longer than 5 years. MGMT methylation status identifies patients most likely to benefit from the addition of temozolomide. FUNDING: EORTC, NCIC, Nelia and Amadeo Barletta Foundation, Schering-Plough.
O(6)-methylguanine-DNA methyltransferase depletion and DNA damage in patients with melanoma treated with temozolomide alone or with lomeguatrib. [2009.04.21]
We evaluated the pharmacodynamic effects of the O(6)-methylguanine-DNA methyltransferase (MGMT) inactivator lomeguatrib (LM) on patients with melanoma in two clinical trials. Patients received temozolomide (TMZ) for 5 days either alone or with LM for 5, 10 or 14 days...
Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. [2009.03.10]
PURPOSE: Approximately 50% of glioblastomas (GBMs) are characterized by overexpression of the epidermal growth factor receptor (EGFR) and EGFR gene amplification. In approximately 25% of instances, constitutively activated EGFR mutants are present. These observations make EGFR-inhibiting drugs a logical approach for trials in recurrent GBM... CONCLUSION: Erlotinib has insufficient single-agent activity in unselected GBM. No clear biomarker associated with improved outcome to erlotinib was identified.
Randomized trial of the combination of lomeguatrib and temozolomide compared with temozolomide alone in chemotherapy naive patients with metastatic cutaneous melanoma. [2007.06.20]
PURPOSE: To evaluate tumor response, pharmacodynamic effects, and safety of a combination of lomeguatrib (LM), an O6-methylguanine DNA-methyltransferase (MGMT) inactivator, and temozolomide (TMZ), TMZ alone, and LM/TMZ after disease progression on TMZ alone in patients with advanced melanoma... CONCLUSION: The efficacy of LM and TMZ in the current dosing schedule is similar to that of TMZ alone. To maintain MGMT depletion in tumor dosing of LM needs to be continued beyond that of TMZ.
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/m² 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 Temodar® in combo w O6-benzylguanine
administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize
toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w
progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar®
in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment
cycle between days 7 & 14 in pts w progressive/recurrent GBM To obtain preliminary response
rates of Temodar® 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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