Trial Outcomes & Findings for Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma (NCT NCT00072358)
NCT ID: NCT00072358
Last Updated: 2022-05-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
291 participants
Primary outcome timeframe
3 years
Results posted on
2022-05-16
Participant Flow
Participant milestones
| Measure |
Participants With Refractory Bone Marrow Disease and High Risk of Recurrence
Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups
|
|---|---|
|
Overall Study
STARTED
|
291
|
|
Overall Study
COMPLETED
|
291
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
Baseline characteristics by cohort
| Measure |
Participants With Refractory Bone Marrow Disease and High Risk of Recurrence
n=291 Participants
Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups
|
|---|---|
|
Age, Continuous
|
4 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
270 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
238 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
291 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 yearsPopulation: 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
SECONDARY outcome
Timeframe: 3 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Participants With Refractory Bone Marrow Disease and High Risk of Recurrence
Serious events: 153 serious events
Other events: 287 other events
Deaths: 135 deaths
Serious adverse events
| Measure |
Participants With Refractory Bone Marrow Disease and High Risk of Recurrence
n=291 participants at risk
Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.34%
1/291 • 2 years
|
|
Immune system disorders
Allergic Reaction/Hyper
|
3.8%
11/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.34%
1/291 • 2 years
|
|
Nervous system disorders
Ataxia
|
0.34%
1/291 • 2 years
|
|
Blood and lymphatic system disorders
Blood,Bone marrow,other
|
0.34%
1/291 • 2 years
|
|
Nervous system disorders
CNS hemorrhage
|
0.69%
2/291 • 2 years
|
|
Cardiac disorders
Cardiac left vent
|
0.34%
1/291 • 2 years
|
|
Cardiac disorders
Cardiovascular, Arrhythmia other
|
0.34%
1/291 • 2 years
|
|
Cardiac disorders
Cardiovascular, other
|
0.69%
2/291 • 2 years
|
|
Infections and infestations
Catheter-rel inf
|
1.7%
5/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
6/291 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/291 • 2 years
|
|
Nervous system disorders
Depressed level of cons
|
0.34%
1/291 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
8/291 • 2 years
|
|
Gastrointestinal disorders
Dysphagia, esophagitis
|
0.34%
1/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.0%
3/291 • 2 years
|
|
General disorders
Fatigue
|
0.69%
2/291 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
11/291 • 2 years
|
|
General disorders
Fever
|
41.6%
121/291 • 2 years
|
|
Gastrointestinal disorders
GI, other
|
0.69%
2/291 • 2 years
|
|
Nervous system disorders
Headache
|
1.4%
4/291 • 2 years
|
|
Gastrointestinal disorders
Hematemesis
|
0.34%
1/291 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.34%
1/291 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
5/291 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.34%
1/291 • 2 years
|
|
Vascular disorders
Hypertension
|
4.1%
12/291 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.4%
4/291 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.0%
3/291 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.1%
9/291 • 2 years
|
|
Vascular disorders
Hypotension
|
3.4%
10/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
9/291 • 2 years
|
|
Infections and infestations
Infection unk ANC
|
2.1%
6/291 • 2 years
|
|
Infections and infestations
Infection w.out neutropenia
|
19.6%
57/291 • 2 years
|
|
Infections and infestations
Infection with grade 3/4 neut
|
1.0%
3/291 • 2 years
|
|
Infections and infestations
Infection/Feb Neut-Other
|
0.34%
1/291 • 2 years
|
|
Psychiatric disorders
Irritability < 3 years
|
0.34%
1/291 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.69%
2/291 • 2 years
|
|
Ear and labyrinth disorders
Middle ear/hearing
|
0.69%
2/291 • 2 years
|
|
Psychiatric disorders
Mood alteration-anxiety
|
0.34%
1/291 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
2.1%
6/291 • 2 years
|
|
Nervous system disorders
Neurology, other
|
2.1%
6/291 • 2 years
|
|
Investigations
Neutrophils/gran
|
1.7%
5/291 • 2 years
|
|
General disorders
Pain, other
|
1.7%
5/291 • 2 years
|
|
Investigations
Platelets
|
0.34%
1/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.34%
1/291 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.34%
1/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
0.34%
1/291 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash, desquamation
|
0.69%
2/291 • 2 years
|
|
General disorders
Rigors, chills
|
6.2%
18/291 • 2 years
|
|
Investigations
SGPT (ALT)
|
1.0%
3/291 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy, other
|
1.4%
4/291 • 2 years
|
|
Nervous system disorders
Seizure
|
1.4%
4/291 • 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.34%
1/291 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
9/291 • 2 years
|
|
Vascular disorders
Thrombosis
|
0.34%
1/291 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
3/291 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
16/291 • 2 years
|
|
Investigations
Weight loss
|
0.69%
2/291 • 2 years
|
Other adverse events
| Measure |
Participants With Refractory Bone Marrow Disease and High Risk of Recurrence
n=291 participants at risk
Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups.
|
|---|---|
|
General disorders
Pain, other
|
54.0%
157/291 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
48.8%
142/291 • 2 years
|
|
Vascular disorders
Flushing
|
35.4%
103/291 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
34.4%
100/291 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
30.9%
90/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.5%
80/291 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
26.8%
78/291 • 2 years
|
|
General disorders
Fever
|
21.6%
63/291 • 2 years
|
|
General disorders
Edema
|
19.9%
58/291 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
53/291 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash, desquamation
|
14.4%
42/291 • 2 years
|
|
Nervous system disorders
Headache
|
13.7%
40/291 • 2 years
|
|
Gastrointestinal disorders
Diarrhea (Pts w/out col)
|
13.1%
38/291 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
12.0%
35/291 • 2 years
|
|
General disorders
Injection site reaction
|
11.3%
33/291 • 2 years
|
|
Reproductive system and breast disorders
Pulmonary, other
|
11.0%
32/291 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
29/291 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.2%
24/291 • 2 years
|
|
Psychiatric disorders
Mood alteration-anxiety
|
7.6%
22/291 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
6.9%
20/291 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
6.5%
19/291 • 2 years
|
|
General disorders
Fatigue
|
6.2%
18/291 • 2 years
|
|
Vascular disorders
Hypertension
|
6.2%
18/291 • 2 years
|
|
Immune system disorders
Allergy, other
|
5.5%
16/291 • 2 years
|
|
Vascular disorders
Hypotension
|
5.5%
16/291 • 2 years
|
|
Psychiatric disorders
Irritability < 3 years
|
5.5%
16/291 • 2 years
|
Additional Information
Dr. Brian Kushner, MD
Memorial Sloan Kettering Cancer Center
Phone: 1-833-MSK KIDS
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place