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Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00323115
First received: May 4, 2006
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: August 24, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Biological: Autologous Dendritic Cell
Drug: Temozolomide
Procedure: Radiotherapy
Biological: Dendritic Cell Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between May 2006 and February 2008, 60 patients were diagnosed with GBM at our institution. Of 11 patients who entered the study, 1 had a seizure with neurologic deterioration several weeks after leukapheresis and did not receive any DC vaccinations.

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
Vaccine Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression

Participant Flow for 2 periods

Period 1:   Vaccine Administration
    Vaccine  
STARTED     11  
COMPLETED     10  
NOT COMPLETED     1  
Adverse Event                 1  

Period 2:   Adjuvant Therapy & Survival Follow-Up
    Vaccine  
STARTED     10  
COMPLETED     2  
NOT COMPLETED     8  
Death                 8  



  Baseline Characteristics
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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
Vaccine Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression

Baseline Measures
    Vaccine  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation
  63.273  ± 9.53  
Gender  
[units: participants]
 
Female     6  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
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1.  Primary:   Tumor-specific Cytotoxic T-cell Response   [ Time Frame: Day 42 ]

2.  Secondary:   Progression Free Survival (PFS)and Overall Survival (OS) Comparison to Prognostic Matched Historical Controls   [ Time Frame: From Enrollment - March 2011 ]

3.  Secondary:   Feasibility and Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination   [ Time Frame: Pheresis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Immunological Parameters With PFS vs Overall Survival   [ Time Frame: Evaluable patients for immunologic parameters are those who have completed 3 vaccines ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Radiological Response When There is Residual Enhancing Tumor at Baseline MRI   [ Time Frame: MRI post vaccine ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Camilo Fadul
Organization: Dartmouth-Hitchcock Medical Center
phone: 603-653-6312
e-mail: camilo.e.fadul@hitchcock.org


Publications of Results:

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00323115     History of Changes
Other Study ID Numbers: D0536
Study First Received: May 4, 2006
Results First Received: August 24, 2012
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration