Trial Outcomes & Findings for Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma (NCT NCT00578864)
NCT ID: NCT00578864
Last Updated: 2020-03-27
Results Overview
Partial response or better
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
2 months
Results posted on
2020-03-27
Participant Flow
Participant milestones
| Measure |
Phase II Window With Protracted Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase II Window With Protracted Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma
Baseline characteristics by cohort
| Measure |
Phase II Window With Protracted Etoposide
n=7 Participants
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
n=6 Participants
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.9 month
n=39 Participants
|
25.3 month
n=41 Participants
|
26.9 month
n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPartial response or better
Outcome measures
| Measure |
Phase II Window With Protracted Etoposide
n=7 Participants
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
n=6 Participants
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 monthsIf a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC \> 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia
Outcome measures
| Measure |
Phase II Window With Protracted Etoposide
n=7 Participants
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
n=6 Participants
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: number of survival
Outcome measures
| Measure |
Phase II Window With Protracted Etoposide
n=7 Participants
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
n=6 Participants
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 monthsthe measure is the number of patients who have surgery after two cycles of induction
Outcome measures
| Measure |
Phase II Window With Protracted Etoposide
n=7 Participants
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
n=6 Participants
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe first of the two events (relapse or death) was chosen to represent disease free survival
Outcome measures
| Measure |
Phase II Window With Protracted Etoposide
n=7 Participants
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
n=6 Participants
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
|
2 Participants
|
1 Participants
|
Adverse Events
Phase II Window With Protracted Etoposide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase II Window With Bolus Etoposide
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase II Window With Protracted Etoposide
n=7 participants at risk
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
|
Phase II Window With Bolus Etoposide
n=6 participants at risk
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
|
|---|---|---|
|
Immune system disorders
Allergic reaction to Caspofungin
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Hearing- monitoring program
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
ALC
|
28.6%
2/7 • Number of events 9
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
ANC
|
100.0%
7/7 • Number of events 44
|
100.0%
6/6 • Number of events 45
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
7/7 • Number of events 47
|
100.0%
6/6 • Number of events 27
|
|
Blood and lymphatic system disorders
PLT
|
100.0%
7/7 • Number of events 58
|
100.0%
6/6 • Number of events 56
|
|
Blood and lymphatic system disorders
WBC
|
85.7%
6/7 • Number of events 28
|
100.0%
6/6 • Number of events 39
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
INR
|
14.3%
1/7 • Number of events 2
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
PTT
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash- dermatitis assoc XRT (foot)
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Ascites, non-malignant
|
28.6%
2/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
28.6%
2/7 • Number of events 2
|
83.3%
5/6 • Number of events 5
|
|
Gastrointestinal disorders
Oral Mucositis/stomatitis
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomitting
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding abdomen
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Febrile Neutropenia
|
100.0%
7/7 • Number of events 12
|
100.0%
6/6 • Number of events 10
|
|
Infections and infestations
Infection
|
28.6%
2/7 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection w/ grade 3 neutropenia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Infection w/ grade 4 neutropenia
|
14.3%
1/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection w/Grade2 ANC
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Infection w/grade 3 ANC
|
28.6%
2/7 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Infections and infestations
Infection w/grade 3/4 ANC
|
14.3%
1/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection w/grade 4 ANC
|
42.9%
3/7 • Number of events 3
|
83.3%
5/6 • Number of events 11
|
|
Infections and infestations
Infection w/normal ANC
|
57.1%
4/7 • Number of events 6
|
33.3%
2/6 • Number of events 4
|
|
Infections and infestations
Infection w/unknown ANC (suspected yeast)
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with Gr 3/4 neutropenia (candida)
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Syphillis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
edema-trunk
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
ALT
|
28.6%
2/7 • Number of events 4
|
33.3%
2/6 • Number of events 3
|
|
Metabolism and nutrition disorders
AST
|
28.6%
2/7 • Number of events 4
|
50.0%
3/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Acidosis
|
14.3%
1/7 • Number of events 4
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Bicarbonate
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
GGT
|
71.4%
5/7 • Number of events 6
|
83.3%
5/6 • Number of events 7
|
|
Metabolism and nutrition disorders
Hemoglobin
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
28.6%
2/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
3/7 • Number of events 4
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
42.9%
3/7 • Number of events 4
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
71.4%
5/7 • Number of events 11
|
66.7%
4/6 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
42.9%
3/7 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
2/7 • Number of events 2
|
66.7%
4/6 • Number of events 6
|
|
Metabolism and nutrition disorders
Sodium
|
0.00%
0/7
|
16.7%
1/6 • Number of events 4
|
|
Nervous system disorders
Somnolence/depressed lvl consc.
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
42.9%
3/7 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection with normal ANC (parainfluenza)
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.6%
2/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Vessel Injury/hepatic splenic arteries
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place