Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Marmara University25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent

Interventions

TemozolomideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Marmara University Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Progression-free Survival at 6-months

Time frame: Until progression

Data from ClinicalTrials.gov

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