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Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-Grade Gliomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Tumor, Recurrent

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Trial Information

Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-Grade Gliomas


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6-months

Outcome Time Frame:

Until progression

Safety Issue:

No

Principal Investigator

Ufuk ABACIOGLU, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Marmara University Hospital, Radiation Oncology Department

Authority:

Turkey: Ministry of Health

Study ID:

MU-RO-2005-1

NCT ID:

NCT00575887

Start Date:

August 2006

Completion Date:

February 2009

Related Keywords:

  • Glioblastoma
  • Astrocytoma
  • Oligodendroglioma
  • Brain Tumor, Recurrent
  • Temozolomide
  • Brain Tumor, Recurrent
  • Chemotherapy
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Oligodendroglioma

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