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

NCT00705198 | Completed

• 1 other identifier: P05062
• Study Type: observational
• Target: 1,804
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioma; Astrocytoma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  One year after start of temozolomide treatment.

• Efficacy in all newly diagnosed anaplastic astrocytoma patients:, evaluated as 5 year survival rate and overall survival.

  From the start of treatment with temozolomide to final outcome.

Study Arms (3)

Newly diagnosed patients

Patients treated with temozolomide for newly diagnosed malignant glioma

Drug: Temozolomide (for newly diagnosed malignant glioma); Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)

Relapsed patients

Patients treated with temozolomide for relapsed malignant glioma

Drug: Temozolomide (for relapsed malignant glioma)

Newly diagnosed anaplastic astrocytoma patients

Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma

Drug: Temozolomide (for newly diagnosed malignant glioma); Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)

Interventions

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.

Also known as: Temodal, Temodar, SCH 052365

Newly diagnosed anaplastic astrocytoma patients; Newly diagnosed patients

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.

Also known as: Temodal, Temodar, SCH 052365

Relapsed patients

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.

Also known as: Radiation therapy

Newly diagnosed anaplastic astrocytoma patients; Newly diagnosed patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Glioma; Astrocytoma

Interventions

Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: September 1, 2006
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11