Trial Outcomes & Findings for Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (NCT NCT03043391)
NCT ID: NCT03043391
Last Updated: 2024-04-08
Results Overview
Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
14 days after treatment with PVSRIPO
Results posted on
2024-04-08
Participant Flow
Participant milestones
| Measure |
All Participants Treated
All participants received a single lerapolturev infusion.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
Baseline characteristics by cohort
| Measure |
All Participants Treated
n=8 Participants
All participants received a single open-label infusion of lerapolturev
|
|---|---|
|
Age, Continuous
|
16.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 14 days after treatment with PVSRIPOPercentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment
Outcome measures
| Measure |
All Participants Treated
n=8 Participants
All participants received a single open-label infusion of lerapolturev
|
|---|---|
|
Percentage of Participants With Unacceptable Toxicity
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 1 yearThe percentage of participants requiring low-dose bevcizumab or steroid due to an inflammatory reaction secondary to an immune response to lerapolturev treatment
Outcome measures
| Measure |
All Participants Treated
n=8 Participants
All participants received a single open-label infusion of lerapolturev
|
|---|---|
|
Percentage of Participants Requiring Low-dose Bevacizumab or Steroid
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: up to 24 monthsEstimation of overall survival calculated at the time between lerapolturev infusion and death or last follow-up if the participant is alive using the Kaplan-Meier method
Outcome measures
| Measure |
All Participants Treated
n=8 Participants
All participants received a single open-label infusion of lerapolturev
|
|---|---|
|
Overall Survival
|
4.1 months
Interval 1.2 to 10.1
|
Adverse Events
All Participants Treated
Serious events: 5 serious events
Other events: 8 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
All Participants Treated
n=8 participants at risk
All participants received a single open-label infusion of lerapolturev
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Seizure
|
25.0%
2/8 • Number of events 2 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Cardiac disorders
Cardiac Arrest
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Immune system disorders
Hypersensitivity
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Dysarthria
|
12.5%
1/8 • Number of events 2 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Cognitive disorder
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
Other adverse events
| Measure |
All Participants Treated
n=8 participants at risk
All participants received a single open-label infusion of lerapolturev
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Dysphasia
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
General disorders
Edema face
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Gastrointestinal disorders
Fatigue
|
37.5%
3/8 • Number of events 3 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 6 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Memory impairment
|
25.0%
2/8 • Number of events 2 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - other, specify
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Nervous system disorders - other
|
37.5%
3/8 • Number of events 5 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Eye disorders
Papilledema
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Pyramidal tract syndrome
|
25.0%
2/8 • Number of events 2 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60