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Trial record 38 of 214 for:    Louisville AND placement

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Decitabine/Vaccine Therapy
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Physician Decision                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Decitabine/Vaccine Therapy

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


Baseline Measures
   Decitabine/Vaccine Therapy 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   1 


  Outcome Measures

1.  Primary:   Tolerability (Number of Participants Without Adverse Events)   [ Time Frame: 20 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: nancy.alsip@louisville.edu



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