NCT04523688 Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma
| NCT ID | NCT04523688 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2021-03-25 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2021-03-25 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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 radiochemotherapy treatment (Stupp regimen) for the disease. For the pre-screening phase of the study the eligibility criteria are: 1. Histologically confirmed "monofocal" glioblastoma 2. Near-complete resection (= 5 ml residual tumor volume) confirmed by "central neuroradiologist on magnetic resonance imaging (MRI) or CT scan within 72 h postoperative" 3. Karnofsky performance status (KPS) = 70% or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Appendix A) 4. Be willing and able to provide written informed consent/assent for the pre-screening phase of the trial. 5. Be = 18 years of age on day of signing informed consent. 6. Life expectancy of greater than 12 weeks. 7. 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 examination); evaluation by transfusionist to exclude possible contraindications to leukapheresis. 8. Patient candidate to standard radiochemotherapy (Stupp regimen) 9. Appropriate 12-lead ECG and echocardiogram. After pre-screening, patient will be enrolled based on subsequent Inclusion Criteria: 1. Histologically confirmed "monofocal" glioblastoma 2. 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 RICOVERO E CURA A CARATTERE SCIENTIFICO (IRCCS) AND MUST FULFIL ALL THE ACCEPTANCE CRITERIA PRESCRIBED BY THE GOOD MANUFACTURING PRACTICES (GMP) PROCEDURES. 3. Availability of sufficient leukapheretic material for the preparation of the vaccine product. 4. No progressive disease near-complete resection (= 5 ml residual tumor volume) confirmed by MRI after standard radiochemotherapy treatment (Stupp regimen) 5. Patients must have recovered (grade 1 or less by CTCAE 5.0) from all the events related to previous treatments. 6. Be willing and able to provide written informed consent/assent for the trial. 7. Be \>= 18 years of age on day of signing informed consent. 8. Have a Karnofsky performance status (KPS) = 70% or a performance status of 0 or 1 on the ECOG Performance Scale. 9. Demonstrate adequate organ and marrow function Exclusion Criteria: 1. 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. 2. 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, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 3. Has a known history of active Bacillus Tuberculosis (TB) 4. Previous treatment with a cancer vaccine 5. 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 treated with radical surgery. 6. 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 immunodeficiency virus (HIV), whether actual or previous. 7. Has received a live vaccine within 30 days of planned start of study therapy.
Contact & Investigator
Laura Ridolfi, DR
STUDY CHAIR
IRST IRCCS
Frequently Asked Questions
Who can join the NCT04523688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04523688 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04523688 currently recruiting?
Yes, NCT04523688 is actively recruiting participants. Contact the research team at oriana.nanni@irst.emr.it for enrollment information.
Where is the NCT04523688 trial being conducted?
This trial is being conducted at Meldola, Italy.
Who is sponsoring the NCT04523688 clinical trial?
NCT04523688 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. The principal investigator is Laura Ridolfi, DR at IRST IRCCS. The trial plans to enroll 28 participants.
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