Trial Outcomes & Findings for 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma (NCT NCT01183884)
NCT ID: NCT01183884
Last Updated: 2019-11-14
Results Overview
in patients in second or greater complete or very good partial remission, but at high risk of additional relapse.
TERMINATED
PHASE2
46 participants
2 years
2019-11-14
Participant Flow
Participant milestones
| Measure |
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
|
|---|---|
|
Overall Study
Progressive Disease
|
26
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other Complicating Disease
|
3
|
|
Overall Study
Not Treated
|
1
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma
Baseline characteristics by cohort
| Measure |
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
n=46 Participants
This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
|
|---|---|
|
Age, Continuous
|
6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data not collected
in patients in second or greater complete or very good partial remission, but at high risk of additional relapse.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data not collected
after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data 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 Acid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brian Kushner, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place