Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03400917|
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Glioblastoma||Biological: AV-GBM-1||Phase 2|
This is a single-arm, open-label phase II clinical trial in which approximately 55 patients will be enrolled with the intent to receive AV-GBM-1. Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).
The primary endpoint of this trial is overall survival (OS), death from any cause measured from the date of study enrollment for treatment with AV-GBM-1. Secondary endpoints will include (1) PFS measured from date of enrollment, (2) OS/PFS measured from date of diagnosis and (3) OS/PFS from date of enrollment based on KPS, age, and extent of surgical resection. Tertiary endpoints will include (1) OS/PFS from date of first injection and (2) OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.
Patient Population: Patients 18 years or older with newly diagnosed glioblastoma [World Health Organization (WHO) Grade IV glioma, Grade IV anaplastic astrocytoma, glioblastoma or gliosarcoma, glioblastoma multiforme (GBM)] who have recovered from surgery, for whom an autologous tumor cell culture and leukapheresis product are available, who have a KPS of > 70, and who are about to begin concurrent CT/RT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||June 2023|
Autologous dendritic cells loaded with tumor associated antigens from a short-term cell culture of autologous tumor cells. AV-GBM-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.
Investigational treatment with AV-GBM-1
- Primary Efficacy Endpoint: Overall Survival [ Time Frame: 3 years ]Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1
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): NCT03400917
|Contact: Candace Hsieh, PhD||949-872-2555 ext email@example.com|
|United States, California|
|UC Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Jinah Chung 714-456-5431 firstname.lastname@example.org|
|Principal Investigator: Daniela A Bota, MD, PhD|
|Study Chair:||Robert O Dillman, MD||Aivita Biomedical, Inc.|