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

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ClinicalTrials.gov Identifier: NCT02332889
Recruitment Status : Terminated (Transition to a different immunotherapy strategy in the future at our institution)
First Posted : January 7, 2015
Results First Posted : April 30, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gliomas
Medulloblastoma
Neuroectodermal Tumors, Primitive
Interventions Biological: Vaccine (autologous dendritic cells)
Drug: Decitabine and Hiltonol
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Decitabine/Vaccine Therapy
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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

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Decitabine/Vaccine Therapy
Hide Arm/Group Description

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

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Tolerability (Number of Participants Without Adverse Events)
Hide Description [Not Specified]
Time Frame 20 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine/Vaccine Therapy
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decitabine/Vaccine Therapy
Hide Arm/Group Description

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

All-Cause Mortality
Decitabine/Vaccine Therapy
Affected / at Risk (%)
Total   0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Decitabine/Vaccine Therapy
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Nervous system disorders   
Progressive disease   1/1 (100.00%)  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 5%
Decitabine/Vaccine Therapy
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
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
Name/Title: Nancy Alsip
Organization: University of Louisville
Phone: 5028522905 ext 502
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT02332889     History of Changes
Other Study ID Numbers: 14.0855
First Submitted: October 20, 2014
First Posted: January 7, 2015
Results First Submitted: December 14, 2017
Results First Posted: April 30, 2018
Last Update Posted: May 4, 2018