Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)

The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

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Key information

Conditions

Glioma Astrocytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Sex eligibility

All sexes

Study type

Observational

About this study

Patients are invited to participate in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy).

Exclusion criteria

Patients with a history of hypersensitivity to temozolomide or dacarbazine.
Pregnant women and women who may be pregnant.

Treatment and study plan

Temozolomide (for newly diagnosed malignant glioma)

Drug

Temozolomide treatment for newly diagnosed malignant glioma. The usual dose for adults in combination with radiotherapy is 75 mg/m2 orally once daily for 42 consecutive days. After a 4 week rest period, monotherapy at 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle is administered. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.

Temozolomide is administered as 20 mg and 100 mg capsules.

Other names: Temodal, Temodar, SCH 052365

Temozolomide (for relapsed malignant glioma)

Drug

Temozolomide treatment for relapsed malignant glioma. The usual dose for adults is 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.

Temozolomide is administered as 20 mg and 100 mg capsules.

Other names: Temodal, Temodar, SCH 052365

Radiotherapy (for patients with newly diagnosed malignant glioma)

Radiation

Although the study protocol does not clearly define how long this intervention is applied, radiotherapy is generally administered 5 days/week for 6 weeks to patients with newly diagnosed malignant glioma.

Other names: Radiation therapy

Primary outcomes

Safety: observation of hematology, biochemistry, and adverse events (AEs); evaluation of details of occurrence of AEs and unexpected serious AEs, and evaluation of presence or absence of secondary malignancies and causal relationship with temozolomide.

Time frame: AEs during treatment with temozolomide, serious AEs occurring within 30 days after completion of treatment with temozolomide. Secondary malignancies will be monitored from the start of treatment with temozolomide to final outcome.
Efficacy in patients registered during Period 1, evaluated as Remarkably Effective, Moderately Effective, Stable Disease, Progression, or Not Evaluable, considering tumor responses, progression free survival, overall survival, among other factors.

Time frame: One year after start of temozolomide treatment.
Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival.

Time frame: From the start of treatment with temozolomide to final outcome.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Temodal Capsule All-Case-Registered Surveillance (Designated Drug Use Investigation) - Evaluation of The Safety and Efficacy of Temodal in Patients With Newly Diagnosed Malignant Glioma (Concomitant With Radiotherapy and Then as Monotherapy) and Relapsed Malignant Glioma (as Monotherapy)

Important dates

Study start: 2006
Primary completion: 2016
Study completion: 2016
First posted: Jun 25, 2008
Registry last updated: Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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