Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma (ATTAC-P)
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|ClinicalTrials.gov Identifier: NCT03615404|
Recruitment Status : Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Malignant Glioma Medulloblastoma Recurrent Pediatric Glioblastoma Multiforme Pediatric Brain Tumor, Recurrent Pediatric Brain Tumor||Biological: CMV-DCs with GM-CSF Biological: Td (tetanus toxoid)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma|
|Actual Study Start Date :||October 5, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: CMV-DCs with GM-CSF and Td (tetanus toxoid)
CMV-DCs are autologous dendritic cells derived from peripheral blood mononuclear cells (PBMCs) loaded with ribonucleic acid (RNA) encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF and Td vaccine as adjuvants.
Biological: CMV-DCs with GM-CSF
CMV-DCs are autologous dendritic cells derived from PBMCs loaded with RNA encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF.
Other Name: pp65-flLAMP DC with GM-CSF
Biological: Td (tetanus toxoid)
Patients will receive preconditioning with Td in the right groin, and approximately 6-24 hours later, they will receive their first CMV-DC vaccination. Patients will also receive Td preconditioning approximately 6-24 hours prior to their 4th vaccine and subsequent vaccines, if any.
Other Name: Tetanus and Diphtheria Toxoid
- Percentage of patients for whom 3 or more vaccines can be made [ Time Frame: 1 year ]Percentage of patients for whom three or more vaccines can be generated from the pre-treatment leukapheresis
- Percentage of patients who experience unacceptable toxicity [ Time Frame: 1 year ]Percentage of patients who experience unacceptable toxicity from CMV-DC administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615404
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Daniel Landi, MD||Duke University|