Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients With Newly Diagnosed 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 : March 20, 2019
Enrollment in this study is being temporarily held for maintenance of the the facility that manufactures study vaccine.
The purpose of this study is to determine the feasibility and safety of administering CMV RNA-pulsed dendritic cells (DCs), also known as CMV-DCs, to children with newly diagnosed WHO Grade IV glioma, recurrent malignant glioma, or patients up to 35 years old with recurrent medulloblastoma. Evidence for efficacy will also be sought. This will be a phase 1 study evaluating CMV-DC administration with tetanus toxoid (Td) preconditioning and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) adjuvant in children with newly diagnosed glioblastoma (GBM), recurrent malignant glioma, or patients up to 35 years old with recurrent medulloblastoma. This safety study will enroll a maximum of 10 patients.
|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)|
|Estimated Enrollment :||10 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 With Newly Diagnosed 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 :||October 2022|
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|