Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma

NCT04523688 | Recruiting Phase 2

• 1 other identifier: IRST191.05
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Glioblastoma; Vaccination

Keywords

glioblastoma; dendritic cells; vaccine; temozolomide; Stupp regimen; cellular therapy

Outcome Measures

Primary Outcomes (2)

• clinical activity

  Progression free survival (PFS), measured as the proportion of patients without progression of disease at three months from leukapheresis

  about 55 months

• Incidence of Treatment-Emergent Adverse Events

  Proportion of patients experienced grade 3 or higher adverse events related to the study treatment

  about 55 months

Secondary Outcomes (4)

• Immune response in vivo

  about 32 months

• Clinical Outcome (Overall Survival (OS))

  about 55 months

• Immunological efficacy

  about 55 months

• Human leukocyte antigen (HLA) class I and II characterization characterization of patients

  about 32 months

Study Arms (1)

Experimental treatment

EXPERIMENTAL

Induction phase: 4 weekly doses of dendritic cell vaccine (10x10exp6 cells) intradermally administered (weeks 1-4). Maintenance phase: 28 days cycles with vaccine administration (start on week 7) and adjuvant temozolomide (150-200mg/m2/day) assumed orally from day 1 to 5 q28 (start on week 5). The combined maintenance treatment will continue until disease progression, unacceptable toxicity or withdrawal of consent by the patient, or up to a maximum of 1 year of treatments. After disease progression or the end of maintenance phase, is foreseen a one-year follow-up phase for each subject.

Biological: Autologous Dendritic Cells (DC) vaccine; Drug: Temozolomide

Interventions

Autologous Dendritic Cells (DC) vaccine BIOLOGICAL

10×10exp6 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)

Experimental treatment

Temozolomide DRUG

Adjuvant temozolomide assumed orally from day 1 to 5 (start on week 5). Dosage: 150mg/m2/day for the first cycle and 200 mg/m2/day for subsequent cycles (q28).

Experimental treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 RICOVERO E CURA A CARATTERE SCIENTIFICO (IRCCS) AND MUST FULFIL ALL THE ACCEPTANCE CRITERIA PRESCRIBED BY THE GOOD MANUFACTURING PRACTICES (GMP) PROCEDURES.
• 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

You may not qualify if:

• 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, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• 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 treated with radical surgery.
• 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.
• Has received a live vaccine within 30 days of planned start of study therapy.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Vaccines; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Laura Ridolfi, DR

  IRST IRCCS

  STUDY CHAIR

Central Study Contacts

Oriana Nanni, DR

CONTACT

+39 0543739266; oriana.nanni@irst.emr.it

Anna Miserocchi, DR

CONTACT

cc.ubsc@irst.emr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: March 25, 2021
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2024-09

Locations

IT (1)