Trial Outcomes & Findings for 177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma (NCT NCT04167618)
NCT ID: NCT04167618
Last Updated: 2023-10-06
Results Overview
Summary of DLTs in DLT evaluable subjects.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Days 1 through 35 in cycle 1
Results posted on
2023-10-06
Participant Flow
Participant milestones
| Measure |
10 mCi 177Lu-DTPA-omburtamab
Intracerebroventricular administration of 10 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
25 mCi 177Lu-DTPA-omburtamab
Intracerebroventricular administration of 25 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
10 mCi 177Lu-DTPA-omburtamab
Intracerebroventricular administration of 10 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
25 mCi 177Lu-DTPA-omburtamab
Intracerebroventricular administration of 25 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
|---|---|---|
|
Overall Study
Trial terminated by sponsor
|
1
|
1
|
Baseline Characteristics
177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
Baseline characteristics by cohort
| Measure |
10 mCi 177Lu-DTPA-omburtamab
n=1 Participants
Intracerebroventricular administration of 10 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
25 mCi 177Lu-DTPA-omburtamab
n=1 Participants
Intracerebroventricular administration of 25 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Continuous
|
15 years
n=5 Participants
|
8 years
n=7 Participants
|
11.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 35 in cycle 1Summary of DLTs in DLT evaluable subjects.
Outcome measures
| Measure |
10 mCi 177Lu-DTPA-omburtamab
n=1 Participants
Intracerebroventricular administration of 10 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
25 mCi 177Lu-DTPA-omburtamab
n=1 Participants
Intracerebroventricular administration of 25 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
|---|---|---|
|
Dose Limiting Toxicities (DLTs) Part 1
|
0 Participants
|
1 Participants
|
Adverse Events
10 mCi 177Lu-DTPA-omburtamab
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
25 mCi 177Lu-DTPA-omburtamab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mCi 177Lu-DTPA-omburtamab
n=1 participants at risk
Intracerebroventricular administration of 10 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
25 mCi 177Lu-DTPA-omburtamab
n=1 participants at risk
Intracerebroventricular administration of 25 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
|---|---|---|
|
Nervous system disorders
Partial seizures
|
100.0%
1/1 • Number of events 1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
0.00%
0/1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
Other adverse events
| Measure |
10 mCi 177Lu-DTPA-omburtamab
n=1 participants at risk
Intracerebroventricular administration of 10 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
25 mCi 177Lu-DTPA-omburtamab
n=1 participants at risk
Intracerebroventricular administration of 25 mCi 177Lu-DTPA-omburtamab for up to two cycles (Part 1).
177Lu-DTPA-omburtamab: Biological, radiolabeled DPTA-omburtamab
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
100.0%
1/1 • Number of events 1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
|
Investigations
Blood albumin decreased
|
0.00%
0/1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
100.0%
1/1 • Number of events 1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
100.0%
1/1 • Number of events 1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
100.0%
1/1 • Number of events 1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
100.0%
1/1 • Number of events 1 • From 1st dose to 5 weeks after last dose, up to 10 weeks (2 cycles).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place