Trial Outcomes & Findings for Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma (NCT NCT00498927)
NCT ID: NCT00498927
Last Updated: 2016-02-29
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
at 6 months
Results posted on
2016-02-29
Participant Flow
Participant milestones
| Measure |
Temozolomide
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Baseline characteristics by cohort
| Measure |
Temozolomide
n=47 Participants
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 monthsPopulation: Glioblastoma patients
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Temozolomide
n=37 Participants
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
|
|---|---|
|
Progression-free Survival (PFS) Rate at 6 Months
|
19 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Glioblastoma patients
All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.
Outcome measures
| Measure |
Temozolomide
n=37 Participants
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
|
|---|---|
|
Overall Survival
|
7 months
Interval 5.0 to 12.0
|
Adverse Events
Temozolomide
Serious events: 14 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide
n=47 participants at risk
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
|
|---|---|
|
Blood and lymphatic system disorders
AST, SGOT
|
2.1%
1/47 • Number of events 1
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.1%
1/47 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Confusion
|
6.4%
3/47 • Number of events 3
|
|
General disorders
Extremity-lower (gait/walking)
|
4.3%
2/47 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
4.3%
2/47 • Number of events 2
|
|
Infections and infestations
Infection, other
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Mood alteration - Agitation
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Pain - Back
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Pain - Head/headache
|
4.3%
2/47 • Number of events 2
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Seizure
|
4.3%
2/47 • Number of events 2
|
|
General disorders
Speech impairment
|
2.1%
1/47 • Number of events 1
|
|
Cardiac disorders
Thrombosis/thrombus/embolism
|
2.1%
1/47 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
2.1%
1/47 • Number of events 1
|
|
Nervous system disorders
Neurology - Other (specify)
|
2.1%
1/47 • Number of events 1
|
Other adverse events
| Measure |
Temozolomide
n=47 participants at risk
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
|
|---|---|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
6.4%
3/47 • Number of events 3
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
14.9%
7/47 • Number of events 7
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
12.8%
6/47 • Number of events 6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.9%
7/47 • Number of events 7
|
|
Nervous system disorders
Neuropathy: sensory
|
6.4%
3/47 • Number of events 3
|
|
Blood and lymphatic system disorders
Platelets
|
6.4%
3/47 • Number of events 3
|
Additional Information
Dr. Antonio Omuro
Memorial Sloan Kettering Cancer Center
Phone: 212 639 7523
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place