Trial Outcomes & Findings for Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs (NCT NCT02332889)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

20 weeks

Results posted on

2018-05-04

Participant milestones
Measure	Decitabine/Vaccine Therapy Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol Vaccine (autologous dendritic cells \[DC\]): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be \> 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination Decitabine and Hiltonol: Patients will receive 5-aza-2-deoxycytidine (DAC) at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Decitabine/Vaccine Therapy Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol Vaccine (autologous dendritic cells \[DC\]): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be \> 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination Decitabine and Hiltonol: Patients will receive 5-aza-2-deoxycytidine (DAC) at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine
Overall Study Physician Decision	1

Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs

Baseline characteristics by cohort
Measure	Decitabine/Vaccine Therapy n=1 Participants Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be \> 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

Timeframe: 20 weeks

Outcome measures
Measure	Decitabine/Vaccine Therapy n=1 Participants Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be \> 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine
Tolerability (Number of Participants Without Adverse Events)	1 Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Decitabine/Vaccine Therapy n=1 participants at risk Biological/Vaccine: Vaccine (autologous dendritic cells) and Drug: Decitabine and Hiltonol Vaccine (autologous dendritic cells): Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be \> 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination Decitabine and Hiltonol: Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine
Nervous system disorders Progressive disease	100.0% 1/1 • Number of events 1

Adverse event data not reported

University of Louisville

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