Trial Outcomes & Findings for Bevacizumab, Irinotecan and Temozolomide for Relapsed or Refractory Neuroblastoma (NCT NCT01114555)
NCT ID: NCT01114555
Last Updated: 2019-11-21
Results Overview
To evaluate tumor responses to combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
15-35 days after cycle 2
Results posted on
2019-11-21
Participant Flow
Participant milestones
| Measure |
Bevacizumab, Irinotecan and Temozolomide
This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays).
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab, Irinotecan and Temozolomide for Relapsed or Refractory Neuroblastoma
Baseline characteristics by cohort
| Measure |
Bevacizumab, Irinotecan and Temozolomide
n=34 Participants
This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays).
|
|---|---|
|
Age, Continuous
|
6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15-35 days after cycle 2To evaluate tumor responses to combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Outcome measures
| Measure |
Bevacizumab, Irinotecan and Temozolomide
n=34 Participants
This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays).
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|---|---|
|
Overall Responses
Complete Response
|
3 Participants
|
|
Overall Responses
No Response
|
18 Participants
|
|
Overall Responses
Progressive Disease
|
12 Participants
|
|
Overall Responses
Not Treated
|
1 Participants
|
SECONDARY outcome
Timeframe: Patients will be evaluated at least once weekly for toxicity. Observation for toxicities for up to 42 daysTo determine the toxicity of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Outcome measures
| Measure |
Bevacizumab, Irinotecan and Temozolomide
n=34 Participants
This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays).
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|---|---|
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Number of Participants With Treatment Related Toxicity
|
34 Participants
|
SECONDARY outcome
Timeframe: days 1,4, 15 and once between days 22-35 during cycle 1 and cycle 2Population: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab, Irinotecan and Temozolomide
Serious events: 14 serious events
Other events: 33 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Bevacizumab, Irinotecan and Temozolomide
n=34 participants at risk
This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays).
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|---|---|
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Investigations
Alanine aminotransferase increased
|
14.7%
5/34 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
2/34 • 6 months
|
|
General disorders
Chills
|
2.9%
1/34 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/34 • 6 months
|
|
Infections and infestations
Enterocolitis infectious
|
2.9%
1/34 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
1/34 • 6 months
|
|
General disorders
Fever
|
14.7%
5/34 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
2/34 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/34 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/34 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • 6 months
|
|
Renal and urinary disorders
Proteinuria
|
5.9%
2/34 • 6 months
|
|
Nervous system disorders
Seizure
|
2.9%
1/34 • 6 months
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/34 • 6 months
|
Other adverse events
| Measure |
Bevacizumab, Irinotecan and Temozolomide
n=34 participants at risk
This is a phase II study of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.
Bevacizumab, Irinotecan and Temozolomide: Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays).
|
|---|---|
|
Investigations
Thrombocytopenia
|
91.2%
31/34 • 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
85.3%
29/34 • 6 months
|
|
Investigations
Lymphopenia
|
82.4%
28/34 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
79.4%
27/34 • 6 months
|
|
Investigations
Elevated AST
|
76.5%
26/34 • 6 months
|
|
Investigations
Elevated ALT
|
61.8%
21/34 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
55.9%
19/34 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
38.2%
13/34 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.5%
8/34 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
4/34 • 6 months
|
|
Renal and urinary disorders
Proteinuria
|
8.8%
3/34 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • 6 months
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • 6 months
|
Additional Information
Dr. Shakeel Modak, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place