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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705198
First received: June 23, 2008
Last updated: September 26, 2014
Last verified: September 2014
  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.

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.


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)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Estimated Enrollment: 2000
Study Start Date: September 2006
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 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.

Other Names:
  • Temodal
  • Temodar
  • 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 Name: 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:
  • Temodal
  • Temodar
  • 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:
  • Temodal
  • Temodar
  • 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 Name: Radiation therapy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705198     History of Changes
Other Study ID Numbers: P05062
Study First Received: June 23, 2008
Last Updated: September 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014