Trial Outcomes & Findings for Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors (NCT NCT00876993)
NCT ID: NCT00876993
Last Updated: 2023-07-03
Results Overview
Collect and grade the all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Two 28-day cycles
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Dose Level 1
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
6
|
3
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1 - Dose Level 1
n=5 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
n=6 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
n=5 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
n=5 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
n=5 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
9.2 years
n=93 Participants
|
8.5 years
n=4 Participants
|
11.4 years
n=27 Participants
|
9.8 years
n=483 Participants
|
10.6 years
n=36 Participants
|
9.8 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
26 Participants
n=10 Participants
|
|
Diagnosis
Medulloblastoma
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Diagnosis
High Grade Glioma
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Diagnosis
Low Grade Glioma
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
|
Diagnosis
Choroid Plexus Tumors
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Diagnosis
Ependymoma
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Diagnosis
PNET
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
|
Diagnosis
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Two 28-day cyclesCollect and grade the all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant.
Outcome measures
| Measure |
Cohort 1 - Dose Level 1
n=4 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
n=6 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
n=5 Participants
BBevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
|---|---|---|---|---|---|
|
Measurement of Number of Adverse Events
Grade 4 adverse events
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Measurement of Number of Adverse Events
Grade 1 adverse events
|
4 Adverse events
|
6 Adverse events
|
3 Adverse events
|
5 Adverse events
|
3 Adverse events
|
|
Measurement of Number of Adverse Events
Grade 2 adverse events
|
4 Adverse events
|
3 Adverse events
|
3 Adverse events
|
5 Adverse events
|
2 Adverse events
|
|
Measurement of Number of Adverse Events
Grade 3 adverse events
|
3 Adverse events
|
1 Adverse events
|
1 Adverse events
|
4 Adverse events
|
1 Adverse events
|
SECONDARY outcome
Timeframe: Every 2 cycles up to 24 cyclesBest response by MRIs per definitions in the protocol (complete response, partial response, stable disease, progressive disease). MRI's were obtained every 2 cycles and the best response was reported.
Outcome measures
| Measure |
Cohort 1 - Dose Level 1
n=4 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
n=6 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
n=5 Participants
BBevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
|---|---|---|---|---|---|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents.
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents.
Partial Response
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents.
Stable Disease
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents.
Progressive Disease
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 year2 year actual event free survival.with children treated with this protocol
Outcome measures
| Measure |
Cohort 1 - Dose Level 1
n=4 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
n=6 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
n=5 Participants
BBevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
|---|---|---|---|---|---|
|
2 Year Event Free Survival With Children Treated With This Regimen.
|
4 Count of participants
|
6 Count of participants
|
3 Count of participants
|
5 Count of participants
|
3 Count of participants
|
SECONDARY outcome
Timeframe: Two 28 day cyclesNumber participants with grade 3 and 4 hematologic and non-hematologic toxicities. All toxicities are for end of cycle 2.
Outcome measures
| Measure |
Cohort 1 - Dose Level 1
n=4 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
n=6 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
n=5 Participants
BBevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
n=3 Participants
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
|---|---|---|---|---|---|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Vascular
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Other
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Blood/Bone Marrow
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Gastrointestinal
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Metabolic/Laboratory
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Musculoskelatal/Soft Tissue
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.
Grade 3 & 4 Neurology
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
Cohort 1 - Dose Level 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 - Dose Level 0
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 - Dose Level 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 - Dose Level 2
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5 - Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - Dose Level 1
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
n=6 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
|---|---|---|---|---|---|
|
Nervous system disorders
Neurology, other - pneumocephalus
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Vascular disorders
Thrombus - embolism
|
0.00%
0/5 • Two 28 day cycles for each participant
|
16.7%
1/6 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Gastrointestinal disorders
GI illness
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Nervous system disorders
Neurologic deficits
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Nervous system disorders
Shunt malfunction
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
40.0%
2/5 • Number of events 2 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Nervous system disorders
Dystonic reaction
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
40.0%
2/5 • Number of events 2 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
Other adverse events
| Measure |
Cohort 1 - Dose Level 1
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 2 - Dose Level 0
n=6 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 3 - Dose Level 1
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 4 - Dose Level 2
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle
|
Cohort 5 - Dose Level 1
n=5 participants at risk
Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytes
|
40.0%
2/5 • Number of events 2 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Blood and lymphatic system disorders
Neutrophils
|
40.0%
2/5 • Number of events 2 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
40.0%
2/5 • Number of events 2 • Two 28 day cycles for each participant
|
|
Blood and lymphatic system disorders
Lymphocytes
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Gastrointestinal disorders
ALT/AST
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Blood and lymphatic system disorders
Thrombus
|
0.00%
0/5 • Two 28 day cycles for each participant
|
16.7%
1/6 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Nervous system disorders
Pain
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
40.0%
2/5 • Number of events 2 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
|
Nervous system disorders
Syncope/Seizure
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
0.00%
0/6 • Two 28 day cycles for each participant
|
0.00%
0/5 • Two 28 day cycles for each participant
|
60.0%
3/5 • Number of events 3 • Two 28 day cycles for each participant
|
20.0%
1/5 • Number of events 1 • Two 28 day cycles for each participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place