Trial Outcomes & Findings for BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM) (NCT NCT01856933)
NCT ID: NCT01856933
Last Updated: 2021-11-23
Results Overview
The response assessment in neuro-oncology (RANO) will be used to define radiographic response. (PD): A \>25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
3 months until progression, potentially up to 1 year
Results posted on
2021-11-23
Participant Flow
Participant milestones
| Measure |
PSMA ADC
2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM)
Baseline characteristics by cohort
| Measure |
PSMA ADC
n=6 Participants
2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months until progression, potentially up to 1 yearPopulation: Progression
The response assessment in neuro-oncology (RANO) will be used to define radiographic response. (PD): A \>25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Outcome measures
| Measure |
PSMA ADC
n=6 Participants
2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks
|
|---|---|
|
Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.
|
6 participants
|
SECONDARY outcome
Timeframe: at least every 3 weeks for a maximum of 30 post coming off drug, approximately 6 monthsPlease note that toxicities outlined may not all be related to the treatment regimen.
Outcome measures
| Measure |
PSMA ADC
n=6 Participants
2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks
|
|---|---|
|
Number of Patients Who Experienced Toxicities (Adverse Events) Who Received PSMA ADC for Recurrent Glioblastoma.
|
6 Participants
|
Adverse Events
PSMA ADC
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PSMA ADC
n=6 participants at risk
2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks
|
|---|---|
|
Investigations
eye disorder/ vision changes
|
16.7%
1/6 • Number of events 1
|
|
Investigations
H/A
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hypermagnesemia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hypokalemia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Intratumoral hemorrhage
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Nausea
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Thrombocytopenia
|
33.3%
2/6 • Number of events 2
|
|
Investigations
seizure
|
16.7%
1/6 • Number of events 1
|
|
Investigations
UTI
|
16.7%
1/6 • Number of events 1
|
|
Investigations
WBC
|
16.7%
1/6 • Number of events 1
|
|
Investigations
confusion
|
16.7%
1/6 • Number of events 1
|
|
Investigations
muscle weakness/weakness general
|
33.3%
2/6 • Number of events 2
|
|
Investigations
dyspnea
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Facial muscle weakness
|
16.7%
1/6 • Number of events 1
|
|
Investigations
CD4 Lymph count
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Lymphopenia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Anorexia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
syncope
|
33.3%
2/6 • Number of events 2
|
|
Investigations
pain
|
16.7%
1/6 • Number of events 1
|
|
Investigations
perforation-sigmoid
|
16.7%
1/6 • Number of events 1
|
|
Investigations
cholesterol
|
16.7%
1/6 • Number of events 1
|
|
Investigations
creatinine
|
16.7%
1/6 • Number of events 1
|
|
Investigations
hyperglycemia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
hypoalbumin
|
16.7%
1/6 • Number of events 1
|
|
Investigations
troponin
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
PSMA ADC
n=6 participants at risk
2.5 mg/kg, IV, over 60 minutes every 3 weeks
PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks
|
|---|---|
|
Investigations
AKI
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alopecia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
ALT
|
33.3%
2/6 • Number of events 2
|
|
Investigations
AST
|
16.7%
1/6 • Number of events 1
|
|
Investigations
anemia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
edema, lower leg
|
16.7%
1/6 • Number of events 1
|
|
Investigations
eye disorder/ vision changes
|
16.7%
1/6 • Number of events 1
|
|
Investigations
fatigue
|
33.3%
2/6 • Number of events 2
|
|
Investigations
H/A
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hypermagnesemia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hypokalemia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Hyponatremia
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Infection/shingles/thrush
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Nausea
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Neutrophil count
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Thrombocytopenia
|
33.3%
2/6 • Number of events 2
|
|
Investigations
vomiting
|
16.7%
1/6 • Number of events 1
|
|
Investigations
rash- torso
|
16.7%
1/6 • Number of events 1
|
|
Investigations
parathesia/neuropathy
|
16.7%
1/6 • Number of events 1
|
|
Investigations
rash- papular
|
16.7%
1/6 • Number of events 1
|
|
Investigations
urinary incontinence
|
16.7%
1/6 • Number of events 1
|
|
Investigations
right ankle swelling
|
16.7%
1/6 • Number of events 1
|
|
Investigations
UTI
|
16.7%
1/6 • Number of events 1
|
|
Investigations
WBC
|
50.0%
3/6 • Number of events 3
|
|
Investigations
intracerebral hematoma
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Lymphopenia
|
33.3%
2/6 • Number of events 2
|
|
Investigations
dysphasia
|
33.3%
2/6 • Number of events 2
|
|
Investigations
gait disturbance
|
16.7%
1/6 • Number of events 1
|
|
Investigations
cognitive disturbance/impairment
|
33.3%
2/6 • Number of events 2
|
|
Investigations
dysgeusia (taste)
|
16.7%
1/6 • Number of events 1
|
|
Investigations
pain- left calf/leg
|
16.7%
1/6 • Number of events 1
|
Additional Information
Heinrich Elinzano, MD
Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place