This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Vaccination-Dendritic Cells With Peptides for Recurrent Malignant Gliomas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oncovir, Inc.
Information provided by (Responsible Party):
Frank Lieberman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00766753
First received: June 23, 2008
Last updated: March 31, 2017
Last verified: March 2017
Results First Received: March 31, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Malignant Glioma
Interventions: Biological: Dendritic vaccine pulsed with multiple peptides
Biological: The first booster vaccine phase:
Biological: The second booster vaccine phase:

  Participant Flow
  Hide 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
AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)

Participant Flow:   Overall Study
    AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC   AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC
STARTED   11   11 
Received at Least One Vaccine   11   11 
Completed at Least Four Vaccines   10   9 
COMPLETED   11   11 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide 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.
Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines

Reporting Groups
  Description
AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
Total Total of all reporting groups

Baseline Measures
   AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC   AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
Age 
[Units: Years]
Median (Full Range)
 52 
 (37 to 71) 
 46 
 (28 to 63) 
 48 
 (28 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  45.5%      4  36.4%      9  40.9% 
Male      6  54.5%      7  63.6%      13  59.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Experienced Treatment-related Dose Limiting Toxicities (DLT)   [ Time Frame: up to 8 weeks ]

2.  Primary:   Median Time To Progression   [ Time Frame: At baseline, 9, 17, 25, and 33 weeks, and every 3 months; up to 23 months ]

3.  Secondary:   12-month- Progression Free Survival (PFS)   [ Time Frame: Up to 12 months ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 102 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Frank Lieberman
Organization: University of Pittsburgh Cancer Institute
phone: (412) 648-6507
e-mail: liebermanf@upmc.edu



Responsible Party: Frank Lieberman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00766753     History of Changes
Other Study ID Numbers: 05-115
NIH/NINDS/NCI
1R21CA117152-01A2 ( U.S. NIH Grant/Contract )
Study First Received: June 23, 2008
Results First Received: March 31, 2017
Last Updated: March 31, 2017