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Temozolomide in Treating Patients With Recurrent High-Grade Glioma

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ClinicalTrials.gov Identifier: NCT00619112
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : October 29, 2013
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Central Nervous System Neoplasm
Intervention Drug: temozolomide
Enrollment 60
Recruitment Details Patients recruited from within established neuro oncology clinic at UCSF. First paient 11.5.2007 and last patient 1.24.2012
Pre-assignment Details  
Arm/Group Title Glioblastoma Grade III Glioma
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 40 20
Completed 39 [1] 18 [2]
Not Completed 1 2
Reason Not Completed
Adverse Event             1             2
[1]
Data from patient who didn't complete study was still included in the final analysis.
[2]
Data from patients who didn't complete study was still included in the final analysis.
Arm/Group Title Glioblastoma Grade III Glioma Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 40 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 20 participants 60 participants
55
(30 to 68)
48
(27 to 70)
53
(27 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 60 participants
Female
12
  30.0%
10
  50.0%
22
  36.7%
Male
28
  70.0%
10
  50.0%
38
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 20 participants 60 participants
40 20 60
1.Primary Outcome
Title 6 Month Progression-free Survival
Hide Description Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
Time Frame First day of treatment until progression or until 6 months mark
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioblastoma Grade III Glioma
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 40 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
10
(3 to 24)
50
(27 to 73)
2.Secondary Outcome
Title Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.
Hide Description 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.
Time Frame First day of treatment until progression or until 6 months mark
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor tissue was available for the exploratory MGMT methylation analysis in 48 patients. In 7 samples the tissue was inadequate for analysis.
Arm/Group Title Glioblastoma With Methylated MGMT Glioblastoma With Unmethylated MGMT Grade III Glioma With Methylated MGMT Grade III Glioma With Unmethylated MGMT
Hide Arm/Group Description:
PFS of Glioblastoma patients with methylated MGMT tumors
PFS of Glioblastoma patients with unmethylated MGMT tumors
PFS of Grade III Glioma patients with methylated MGMT tumors
PFS of Grade III Glioma patients with unmethylated MGMT tumors
Overall Number of Participants Analyzed 7 21 10 3
Median (95% Confidence Interval)
Unit of Measure: weeks
8.14 [1] 
(7.71 to NA)
7.57
(7.29 to 9)
38.1 [1] 
(10.71 to NA)
48.6 [1] 
(6.86 to NA)
[1]
Upper confidence limit for median cannot be estimated (not yet reached).
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame up to 2 years after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioblastoma Grade III Glioma
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 40 20
Median (95% Confidence Interval)
Unit of Measure: weeks
21.6
(16.9 to 30.6)
100.6 [1] 
(67 to NA)
[1]
The upper bound was not reached during length of the study.
4.Secondary Outcome
Title Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System
Hide Description PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.
Time Frame prior to start of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioblastoma Grade III Glioma
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 40 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Patients Progressing After Two First-line Adjuvant Courses of Temozolomide
Hide Description [Not Specified]
Time Frame After two first-line adjuvant courses of temozolomide
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioblastoma Grade III Glioma
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 40 20
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.5%
0
   0.0%
6.Secondary Outcome
Title Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide
Hide Description [Not Specified]
Time Frame Within 6 months after 6th adjuvant course of temozolomide
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioblastoma Grade III Glioma
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 40 20
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.0%
1
   5.0%
7.Secondary Outcome
Title Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued
Hide Description [Not Specified]
Time Frame From beginning of voluntarily temozolomide discontinued up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioblastoma Grade III Glioma
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 40 20
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.0%
4
  20.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temozolomide
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Temozolomide
Affected / at Risk (%)
Total   0/60 (0.00%) 
Hide Serious Adverse Events
Temozolomide
Affected / at Risk (%)
Total   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Temozolomide
Affected / at Risk (%)
Total   38/60 (63.33%) 
Eye disorders   
Eye disorders - Other, specify   1/60 (1.67%) 
Gastrointestinal disorders   
Dysphagia   1/60 (1.67%) 
Nausea   1/60 (1.67%) 
General disorders   
Fatigue   2/60 (3.33%) 
Pain   2/60 (3.33%) 
Infections and infestations   
Skin infection   1/60 (1.67%) 
Injury, poisoning and procedural complications   
Vascular access complication   1/60 (1.67%) 
Investigations   
Lymphocyte count decreased   28/60 (46.67%) 
White blood cell decreased   7/60 (11.67%) 
Neutrophil count decreased   4/60 (6.67%) 
Platelet count decreased   4/60 (6.67%) 
Metabolism and nutrition disorders   
Hyperglycemia   2/60 (3.33%) 
Hypokalemia   1/60 (1.67%) 
Hyponatremia   1/60 (1.67%) 
Nervous system disorders   
Peripheral motor neuropathy   6/60 (10.00%) 
Depressed level of consciousness   3/60 (5.00%) 
Seizure   2/60 (3.33%) 
Dysphasia   2/60 (3.33%) 
Nervous system disorders - Other, specify   1/60 (1.67%) 
Psychiatric disorders   
Confusion   1/60 (1.67%) 
Indicates events were collected by systematic assessment
The trial reached enrollment. There were no unexpected toxicities.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicholas Butowski
Organization: UCSF
Phone: 4153532966
EMail: Butowski@neurosurg.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00619112    
Obsolete Identifiers: NCT00539552
Other Study ID Numbers: UCSF-07107
SPRI-UCSF-H44867-31182-01
First Submitted: February 19, 2008
First Posted: February 20, 2008
Results First Submitted: June 17, 2013
Results First Posted: October 29, 2013
Last Update Posted: January 31, 2018