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

November 11, 2016 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are invited to participate in the study.

Study Type

Observational

Enrollment (Actual)

1804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy). In addition, up to 450 patients with newly diagnosed anaplastic astrocytoma will be registered to investigate survival time.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly diagnosed patients
Patients treated with temozolomide for newly diagnosed malignant glioma
Drug: Temozolomide (for newly diagnosed malignant glioma)

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:
  • Temodar
  • Temodal
  • SCH 052365
Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)
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
Relapsed patients
Patients treated with temozolomide for relapsed malignant glioma
Drug: Temozolomide (for relapsed malignant glioma)

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:
  • Temodar
  • Temodal
  • SCH 052365
Newly diagnosed anaplastic astrocytoma patients
Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma
Drug: Temozolomide (for newly diagnosed malignant glioma)

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:
  • Temodar
  • Temodal
  • SCH 052365
Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
From the start of treatment with temozolomide to final outcome.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 11, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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