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

Purpose

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.

Condition	Intervention
Glioma Astrocytoma	Drug: Temozolomide (for newly diagnosed malignant glioma) Drug: Temozolomide (for relapsed malignant glioma) Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Temozolomide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official 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)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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. 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.
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.
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. 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.

Detailed Description:

Patients are invited to participate in the study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05062
First Received:	June 23, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00705198
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Neuroectodermal Tumors

Astrocytoma

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Glioma

Temozolomide

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Antineoplastic Agents, Alkylating

Neoplasms, Neuroepithelial

Alkylating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705198