BridgeMD
New treatment option for Glioblastoma
Official title Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma
ClinicalTrials.gov ID: NCT04523688
What this study is testing
What is Autologous Dendritic Cells (DC) vaccine?
Autologous Dendritic Cells (DC) vaccine is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Single arm, monocentric trial to assess the safety and the progression-free survival related to the combined treatment of dendritic cell vaccine loaded with autologous tumor homogenate and temozolomide in patients operated for glioblastoma and then treated with standard radiochemotherapy (according to Stupp regimen).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- After signing the informed consent form for pre-screening, patient will assess the procedures to obtain sufficient leukapheretic material for the...
- Histologically confirmed "monofocal" glioblastoma
- Near-complete resection (= 5 ml residual tumor volume) confirmed by "central neuroradiologist on magnetic resonance imaging (MRI) or CT scan within...
- Karnofsky performance status (KPS) = 70% or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Appendix...
- Be willing and able to provide written informed consent/assent for the pre-screening phase of the trial.
You likely can't join if
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \> 10 mg prednisone equivalent or any other form of immunosuppressive...
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or...
- Has a known history of active Bacillus Tuberculosis (TB)
- Previous treatment with a cancer vaccine
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years, except basal or...
- Any known history of or is positivity of any serologic marker indicative of infection by Treponema pallidum, hepatitis B virus (HBsAg, HBsAb, HBcAB)...
See the full eligibility criteria
- After signing the informed consent form for pre-screening, patient will assess the procedures to obtain sufficient leukapheretic material for the dendritic cell vaccine manufacturing and will perform the standard...
- Histologically confirmed "monofocal" glioblastoma
- Near-complete resection (= 5 ml residual tumor volume) confirmed by "central neuroradiologist on magnetic resonance imaging (MRI) or CT scan within 72 h postoperative"
- Karnofsky performance status (KPS) = 70% or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Appendix A)
- Be willing and able to provide written informed consent/assent for the pre-screening phase of the trial.
- Be = 18 years of age on day of signing informed consent.
- Life expectancy of greater than 12 weeks.
- Patient suitable for the collection of biological material from leukapheresis: serological tests HIV, hepatitis B virus (HBV), HCV, Treponema pallidum negative; normal cardiological parameters (ECG and cardiological...
- Patient candidate to standard radiochemotherapy (Stupp regimen)
- Appropriate 12-lead ECG and echocardiogram. After pre-screening, patient will be enrolled based on subsequent
- Histologically confirmed "monofocal" glioblastoma
- THE AUTOLOGOUS SURGICAL SPECIMEN NEEDED FOR VACCINE MANUFACTURING MUST HAVE BEEN COLLECTED AND SENT TO THE SOMATIC CELL THERAPY LAB OF ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) ISTITUTO DI...
- Availability of sufficient leukapheretic material for the preparation of the vaccine product.
- No progressive disease near-complete resection (= 5 ml residual tumor volume) confirmed by MRI after standard radiochemotherapy treatment (Stupp regimen)
- Patients must have recovered (grade 1 or less by CTCAE 5.0) from all the events related to previous treatments.
- Be willing and able to provide written informed consent/assent for the trial.
- Be \>= 18 years of age on day of signing informed consent.
- Have a Karnofsky performance status (KPS) = 70% or a performance status of 0 or 1 on the ECOG Performance Scale.
- Demonstrate adequate organ and marrow function
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \> 10 mg prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine...
- Has a known history of active Bacillus Tuberculosis (TB)
- Previous treatment with a cancer vaccine
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years, except basal or squamous cell carcinoma of the skin and in situ carcinoma of the cervix uteri...
- Any known history of or is positivity of any serologic marker indicative of infection by Treponema pallidum, hepatitis B virus (HBsAg, HBsAb, HBcAB), hepatitis C virus (HCVAb, HCV RNA quantitative), human...
- Has received a live vaccine within 30 days of planned start of study therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Meldola, FC, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Meldola, FC, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.