Trial Outcomes & Findings for 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow (NCT NCT01183897)
NCT ID: NCT01183897
Last Updated: 2019-08-13
Results Overview
against persistent neuroblastoma in bone marrow of patients who have no other evidence of disease by standard studies.
COMPLETED
PHASE2
31 participants
2 years
2019-08-13
Participant Flow
Participant milestones
| Measure |
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow
Baseline characteristics by cohort
| Measure |
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
n=31 Participants
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
|
|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
against persistent neuroblastoma in bone marrow of patients who have no other evidence of disease by standard studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
to test the hypothesis that the minimal residual disease content of bone marrow after the first treatments with 3F8/GMCSF has significant prognostic impact on progression-free survival.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.
Outcome measures
Outcome data not reported
Adverse Events
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Kushner MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place