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Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00725010
First received: July 25, 2008
Last updated: November 29, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.


Condition Intervention
Glioblastoma
 Drug: Temozolomide
Radiation: Radiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Safety: Number of Adverse Events in the Indicated Categories [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinued Due to Toxicity [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
 Drug: Temozolomide
Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.
Other Names:
  • Temodal
  • Temodar
  • SCH 052365
Radiation: Radiotherapy
Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
Other Names:
  • Radiation therapy
  • Irradiation

Detailed Description:

Participant sampling method: consecutive patient sampling.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with newly diagnosed Glioblastoma multiforme

Criteria

Inclusion Criteria:

  • Newly diagnosed Glioblastoma multiforme

Exclusion Criteria:

  • History of hypersensitivity to temozolomide or its components, or to dacarbazine.
  • Women who are pregnant or breast-feeding.
  • Patients with severe myelosuppression.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00725010     History of Changes
Other Study ID Numbers: P04816
Study First Received: July 25, 2008
Results First Received: October 22, 2010
Last Updated: November 29, 2010
Health Authority: Austria: No Health Authority approval required according to local law.

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

ClinicalTrials.gov processed this record on May 16, 2013