Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Ufuk ABACIOGLU, Marmara University
ClinicalTrials.gov Identifier:
NCT00575887
First received: December 17, 2007
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.


Condition Intervention Phase
Glioblastoma
Astrocytoma
Oligodendroglioma
Brain Tumor, Recurrent
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas

Resource links provided by NLM:


Further study details as provided by Marmara University:

Primary Outcome Measures:
  • Progression-free Survival at 6-months [ Time Frame: Until progression ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Temozolomide
100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
Other Names:
  • Temodal
  • Temodar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age >18 years old
  • Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)
  • Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging
  • Karnofsky Performance Status scale >/=50 (due to brain pathology)
  • Adequate hematological, renal and hepatic function
  • Patients willing to participate in the study and signing the informed consent

Exclusion Criteria:

  • Karnofsky Performance Status scale <50
  • Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study
  • Patients not suitable for follow-up
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575887

Locations
Turkey
Marmara University Hospital
Istanbul, Turkey, 34660
Sponsors and Collaborators
Marmara University
Schering-Plough
Investigators
Study Chair: Ufuk ABACIOGLU, MD Marmara University Hospital, Radiation Oncology Department
  More Information

Publications:
Responsible Party: Ufuk ABACIOGLU, Assoc. Prof., Marmara University
ClinicalTrials.gov Identifier: NCT00575887     History of Changes
Other Study ID Numbers: MU-RO-2005-1
Study First Received: December 17, 2007
Results First Received: November 3, 2013
Last Updated: November 3, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Marmara University:
Temozolomide
Brain Tumor, Recurrent
Chemotherapy

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Glioblastoma
Oligodendroglioma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
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 November 20, 2014