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BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM)

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ClinicalTrials.gov Identifier: NCT01856933
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : June 17, 2015
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
Progenics Pharmaceuticals, Inc.
Rhode Island Hospital
University of Texas
Information provided by (Responsible Party):
Heinrich Elinzano, MD, Brown University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions GBM
Glioblastoma Multiforme
Gliosarcoma
Intervention Drug: PSMA ADC
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PSMA ADC
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2.5 mg/kg, IV, over 60 minutes every 3 weeks

PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title PSMA ADC
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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 Number of Baseline Participants 6
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  66.7%
>=65 years
2
  33.3%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
60.3
(39 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.
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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).

Time Frame 3 months until progression, potentially up to 1 year
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Progression
Arm/Group Title PSMA ADC
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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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
6
2.Secondary Outcome
Title Toxicities (Adverse Events) of PSMA ADC for Patients With Recurrent Glioblastoma.
Hide Description [Not Specified]
Time Frame at least every 3 weeks for a maximum of 30 post coming off drug, approximtely 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title PSMA ADC
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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 Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PSMA ADC
Hide Arm/Group Description

2.5 mg/kg, IV, over 60 minutes every 3 weeks

PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks

All-Cause Mortality
PSMA ADC
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PSMA ADC
Affected / at Risk (%) # Events
Total   4/6 (66.67%)    
Investigations   
eye disorder/ vision changes   1/6 (16.67%)  1
H/A   1/6 (16.67%)  1
Hypermagnesemia   1/6 (16.67%)  1
Hypokalemia   1/6 (16.67%)  1
Intratumoral hemorrhage   1/6 (16.67%)  1
Nausea   1/6 (16.67%)  1
Thrombocytopenia   2/6 (33.33%)  2
seizure   1/6 (16.67%)  1
UTI   1/6 (16.67%)  1
WBC   1/6 (16.67%)  1
confusion   1/6 (16.67%)  1
muscle weakness/weakness general   2/6 (33.33%)  2
dyspnea   1/6 (16.67%)  1
Facial muscle weakness   1/6 (16.67%)  1
CD4 Lymph count   2/6 (33.33%)  2
Lymphopenia   1/6 (16.67%)  1
Anorexia   1/6 (16.67%)  1
syncope   2/6 (33.33%)  2
pain   1/6 (16.67%)  1
perforation-sigmoid   1/6 (16.67%)  1
cholesterol   1/6 (16.67%)  1
creatinine   1/6 (16.67%)  1
hyperglycemia   1/6 (16.67%)  1
hypoalbumin   1/6 (16.67%)  1
troponin   1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PSMA ADC
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Investigations   
AKI   1/6 (16.67%)  1
Alopecia   1/6 (16.67%)  1
ALT   2/6 (33.33%)  2
AST   1/6 (16.67%)  1
anemia   1/6 (16.67%)  1
edema, lower leg   1/6 (16.67%)  1
eye disorder/ vision changes   1/6 (16.67%)  1
fatigue   2/6 (33.33%)  2
H/A   1/6 (16.67%)  1
Hypermagnesemia   1/6 (16.67%)  1
Hypokalemia   1/6 (16.67%)  1
Hyponatremia   2/6 (33.33%)  2
Infection/shingles/thrush   2/6 (33.33%)  2
Nausea   1/6 (16.67%)  1
Neutrophil count   1/6 (16.67%)  1
Thrombocytopenia   2/6 (33.33%)  2
vomiting   1/6 (16.67%)  1
rash- torso   1/6 (16.67%)  1
parathesia/neuropathy   1/6 (16.67%)  1
rash- papular   1/6 (16.67%)  1
urinary incontinence   1/6 (16.67%)  1
right ankle swelling   1/6 (16.67%)  1
UTI   1/6 (16.67%)  1
WBC   3/6 (50.00%)  3
intracerebral hematoma   1/6 (16.67%)  1
Lymphopenia   2/6 (33.33%)  2
dysphasia   2/6 (33.33%)  2
gait disturbance   1/6 (16.67%)  1
cognitive disturbance/impairment   2/6 (33.33%)  2
dysgeusia (taste)   1/6 (16.67%)  1
pain- left calf/leg   1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Heinrich Elinzano, MD
Organization: Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
EMail: kayla_rosati@brown.edu
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Responsible Party: Heinrich Elinzano, MD, Brown University
ClinicalTrials.gov Identifier: NCT01856933     History of Changes
Other Study ID Numbers: 263
First Submitted: January 8, 2013
First Posted: May 20, 2013
Results First Submitted: March 5, 2015
Results First Posted: June 17, 2015
Last Update Posted: April 2, 2019