Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Temodal Temodar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No