A Study of Experimental Autologous Dendritic (immune) Cells With Autologous Tumor Antigens for Newly-Diagnosed Glioblastoma
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| Age: | 18 to 70 years old |
| Gender: |
Any
|
| Healthy Volunteers: | No |
| Keywords: | glioblastoma, autologous cancer therapy, autologous immunotherapy |
| Type: | Biological study, Phase 2 |
| Target: |
6 Participants
|
Investigator:
Description
The Sponsor of the study is AIVITA Biomedical, Inc. Our study team is helping to determine if an experimental immunotherapy (AV-GBM-1) will increase survival without harmful effects. AV-GBM-1 consists of a patient’s own dendritic cells (a type of immune cell). It is loaded with a patient’s own tumor-associated antigens (proteins that are made by their cancer cells) .
The goal of this immunotherapy is to make a patient’s immune response better at fighting the existing tumor and to increase survival. GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. In this study, GM-CSF is given to enhance the immune effects of the treatment products.
AV-GBM-1 is an experimental drug. This means it has not been approved by the U.S. Food and Drug Administration (FDA) for standard use in the practice of medicine.
This study requires
The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.
Who can participate
Inclusion criteria:
- Karnofsky Performance Score of 70-100%
- Histology confirmed to be GBM (Grade IV WHO, glioblastoma, gliosarcoma)
- Successful establishment of an autologous cancer cell line by AIVITA Biomedical, Inc.
- Collection of a satisfactory leukapheresis product
- About to begin concurrent CT/RT
- Given written informed consent to participate in the study
Exclusion criteria:
- Known to have active hepatitis B or C or HIV
- Karnofsky Performance Score of < 70%
- Known underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
- Diagnosis of any other invasive cancer or other disease process which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than GBM
- Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
- Known autoimmune disease, immunodeficiency, or disease process that involves the chronic use of immunosuppressive therapy.
- Received another investigational drug within 28 days of the first dose or are planning to receive another investigational drug while receiving this investigational treatment.
- Known hypersensitivity to GM-CSF
- Pregnancy
Benefits and risks of participating
BENEFITS:We cannot promise any benefits to you as a result of taking part in this research study.
RISKS:
The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Study ID
UC Davis IRB: 1293528
ClinicalTrials.gov: NCT03400917
Schedule
Study duration and period
This study includes 8 study treatment visits over a period of 24 weeks. After the study, long-term follow up will occur every 3 months for up to three years or the rest of your life or study closure, whichever occurs first. Follow up visits may be done at the same time as your routine clinical visits, or by phone or email.
Recruitment period
From Oct. 17, 2018
| Location |
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Sacramento, CA 95817
Research Topic
Conditions:
- Newly Diagnosed Glioblastoma