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

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ClinicalTrials.gov Identifier: NCT00725010
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : November 18, 2010
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Glioblastoma Drug: Temozolomide Radiation: Radiotherapy

Detailed Description:
Participant sampling method: consecutive patient sampling.
Study Design
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Study Type : Observational
Actual Enrollment : 64 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Number of Adverse Events in the Indicated Categories [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ]
  2. Number of Participants Who Discontinued Due to Toxicity [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725010    
Other Study ID Numbers: P04816
First Posted: July 30, 2008    Key Record Dates
Results First Posted: November 18, 2010
Last Update Posted: September 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents