Trial Outcomes & Findings for Temozolomide in Treating Patients With Recurrent High-Grade Glioma (NCT NCT00619112)
NCT ID: NCT00619112
Last Updated: 2018-01-31
Results Overview
Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
First day of treatment until progression or until 6 months mark
Results posted on
2018-01-31
Participant Flow
Patients recruited from within established neuro oncology clinic at UCSF. First paient 11.5.2007 and last patient 1.24.2012
Participant milestones
| Measure |
Glioblastoma
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
39
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Glioblastoma
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
Temozolomide in Treating Patients With Recurrent High-Grade Glioma
Baseline characteristics by cohort
| Measure |
Glioblastoma
n=40 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=20 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
48 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
20 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First day of treatment until progression or until 6 months markEfficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
Outcome measures
| Measure |
Glioblastoma
n=40 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=20 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma With Methylated MGMT
PFS of Grade III Glioma patients with methylated MGMT tumors
|
Grade III Glioma With Unmethylated MGMT
PFS of Grade III Glioma patients with unmethylated MGMT tumors
|
|---|---|---|---|---|
|
6 Month Progression-free Survival
|
10 percentage of patients
Interval 3.0 to 24.0
|
50 percentage of patients
Interval 27.0 to 73.0
|
—
|
—
|
SECONDARY outcome
Timeframe: First day of treatment until progression or until 6 months markPopulation: Tumor tissue was available for the exploratory MGMT methylation analysis in 48 patients. In 7 samples the tissue was inadequate for analysis.
Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study.
Outcome measures
| Measure |
Glioblastoma
n=7 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=21 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma With Methylated MGMT
n=10 Participants
PFS of Grade III Glioma patients with methylated MGMT tumors
|
Grade III Glioma With Unmethylated MGMT
n=3 Participants
PFS of Grade III Glioma patients with unmethylated MGMT tumors
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.
|
8.14 weeks
Interval 7.71 to
Upper confidence limit for median cannot be estimated (not yet reached).
|
7.57 weeks
Interval 7.29 to 9.0
|
38.1 weeks
Interval 10.71 to
Upper confidence limit for median cannot be estimated (not yet reached).
|
48.6 weeks
Interval 6.86 to
Upper confidence limit for median cannot be estimated (not yet reached).
|
SECONDARY outcome
Timeframe: up to 2 years after treatmentOutcome measures
| Measure |
Glioblastoma
n=40 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=20 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma With Methylated MGMT
PFS of Grade III Glioma patients with methylated MGMT tumors
|
Grade III Glioma With Unmethylated MGMT
PFS of Grade III Glioma patients with unmethylated MGMT tumors
|
|---|---|---|---|---|
|
Overall Survival
|
21.6 weeks
Interval 16.9 to 30.6
|
100.6 weeks
Interval 67.0 to
The upper bound was not reached during length of the study.
|
—
|
—
|
SECONDARY outcome
Timeframe: prior to start of studyPCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.
Outcome measures
| Measure |
Glioblastoma
n=40 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=20 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma With Methylated MGMT
PFS of Grade III Glioma patients with methylated MGMT tumors
|
Grade III Glioma With Unmethylated MGMT
PFS of Grade III Glioma patients with unmethylated MGMT tumors
|
|---|---|---|---|---|
|
Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: After two first-line adjuvant courses of temozolomideOutcome measures
| Measure |
Glioblastoma
n=40 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=20 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma With Methylated MGMT
PFS of Grade III Glioma patients with methylated MGMT tumors
|
Grade III Glioma With Unmethylated MGMT
PFS of Grade III Glioma patients with unmethylated MGMT tumors
|
|---|---|---|---|---|
|
Patients Progressing After Two First-line Adjuvant Courses of Temozolomide
|
3 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 6 months after 6th adjuvant course of temozolomideOutcome measures
| Measure |
Glioblastoma
n=40 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=20 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma With Methylated MGMT
PFS of Grade III Glioma patients with methylated MGMT tumors
|
Grade III Glioma With Unmethylated MGMT
PFS of Grade III Glioma patients with unmethylated MGMT tumors
|
|---|---|---|---|---|
|
Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide
|
4 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From beginning of voluntarily temozolomide discontinued up to 6 monthsOutcome measures
| Measure |
Glioblastoma
n=40 Participants
Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma
n=20 Participants
Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\^2 daily for seven consecutive days of every other week.
One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
|
Grade III Glioma With Methylated MGMT
PFS of Grade III Glioma patients with methylated MGMT tumors
|
Grade III Glioma With Unmethylated MGMT
PFS of Grade III Glioma patients with unmethylated MGMT tumors
|
|---|---|---|---|---|
|
Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued
|
4 Participants
|
4 Participants
|
—
|
—
|
Adverse Events
Temozolomide
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Temozolomide
n=60 participants at risk
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
46.7%
28/60
|
|
Investigations
White blood cell decreased
|
11.7%
7/60
|
|
Investigations
Neutrophil count decreased
|
6.7%
4/60
|
|
Investigations
Platelet count decreased
|
6.7%
4/60
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
6/60
|
|
Nervous system disorders
Depressed level of consciousness
|
5.0%
3/60
|
|
Nervous system disorders
Seizure
|
3.3%
2/60
|
|
Nervous system disorders
Dysphasia
|
3.3%
2/60
|
|
Psychiatric disorders
Confusion
|
1.7%
1/60
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.7%
1/60
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
2/60
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/60
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/60
|
|
General disorders
Fatigue
|
3.3%
2/60
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/60
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60
|
|
General disorders
Pain
|
3.3%
2/60
|
|
Infections and infestations
Skin infection
|
1.7%
1/60
|
|
Eye disorders
Eye disorders - Other, specify
|
1.7%
1/60
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.7%
1/60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place