Trial Outcomes & Findings for Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma (NCT NCT00575887)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Until progression

Results posted on

2013-12-20

Participant milestones
Measure	Dose-Dense Temozolomide 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
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Baseline characteristics by cohort
Measure	Dose-Dense Temozolomide n=25 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age Continuous	50 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment Turkey	25 participants n=5 Participants

Timeframe: Until progression

Outcome measures
Measure	Temozolomide n=25 Participants 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
Progression-free Survival at 6-months	17.3 percentage of participants

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Temozolomide n=25 participants at risk 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
Blood and lymphatic system disorders Lymphopenia	80.0% 20/25 • Number of events 20
Blood and lymphatic system disorders Thrombocytopenia	8.0% 2/25 • Number of events 2

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