Trial Outcomes & Findings for Temozolomide in Treating Patients With Low-Grade Glioma (NCT NCT00313729)
NCT ID: NCT00313729
Last Updated: 2019-02-07
Results Overview
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
12 months
Results posted on
2019-02-07
Participant Flow
Participant milestones
| Measure |
Single Arm Study of Temozolomide for LGG Patients
Oral temozolomide at 200mg/m2 per day x5 days every 28 days for up to 12 cycles
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temozolomide in Treating Patients With Low-Grade Glioma
Baseline characteristics by cohort
| Measure |
Temozolomide
n=120 Participants
Single Arm Trial with single dose schedule of Temozolomide chemotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAssessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
Outcome measures
| Measure |
Temozolomide
n=120 Participants
Temozolomide
temozolomide: Chemotherapy
|
|---|---|
|
Response Rate (Complete and Partial Response)
|
7 Participants
|
SECONDARY outcome
Timeframe: time from registration until date of the first documented progression, an average of 1 yearProgressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
Outcome measures
| Measure |
Temozolomide
n=120 Participants
Temozolomide
temozolomide: Chemotherapy
|
|---|---|
|
Time to Tumor Progression
|
3.8 years
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Time from registration up to 13 monthsNumber of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0
Outcome measures
| Measure |
Temozolomide
n=120 Participants
Temozolomide
temozolomide: Chemotherapy
|
|---|---|
|
Safety Profile
|
12 Participants
|
Adverse Events
Temozolomide
Serious events: 17 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide
n=120 participants at risk
Temozolomide
temozolomide: Chemotherapy
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC)
|
0.83%
1/120 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia (platelets)
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
seizure
|
5.0%
6/120 • Number of events 6
|
|
Nervous system disorders
Headache
|
2.5%
3/120 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
2/120 • Number of events 2
|
|
Nervous system disorders
Hydrocephalus
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Death
|
0.83%
1/120 • Number of events 1
|
Other adverse events
| Measure |
Temozolomide
n=120 participants at risk
Temozolomide
temozolomide: Chemotherapy
|
|---|---|
|
Metabolism and nutrition disorders
Fatigue
|
7.5%
9/120 • Number of events 18
|
|
Gastrointestinal disorders
Nausea
|
9.2%
11/120 • Number of events 17
|
|
Metabolism and nutrition disorders
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
4.2%
5/120 • Number of events 6
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Seizures
|
5.8%
7/120 • Number of events 8
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
3.3%
4/120 • Number of events 5
|
|
Nervous system disorders
Tremor
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Weight loss
|
1.7%
2/120 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
1.7%
2/120 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
6.7%
8/120 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
5/120 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.2%
5/120 • Number of events 11
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
6.7%
8/120 • Number of events 22
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.0%
6/120 • Number of events 19
|
|
Blood and lymphatic system disorders
Platelets
|
4.2%
5/120 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
2/120 • Number of events 3
|
|
Nervous system disorders
Insomnia
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Memory loss
|
0.83%
1/120 • Number of events 1
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
0.83%
1/120 • Number of events 2
|
|
Metabolism and nutrition disorders
GGT (γ-Glutamyl transpeptidase)
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Neuropathy: cranial
|
0.83%
1/120 • Number of events 1
|
|
General disorders
Pain - Other
|
4.2%
5/120 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.7%
2/120 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with high-dose chemotherapy or BMT studies
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
4/120 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.7%
2/120 • Number of events 3
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Personality/behavioral
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Mood alteration - depression
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Wound-infectious
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea patients without colostomy
|
0.83%
1/120 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place