Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme

Launched by FONDAZIONE I.R.C.C.S. ISTITUTO NEUROLOGICO CARLO BESTA · Mar 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment for patients with newly diagnosed glioblastoma multiforme (GBM), a serious type of brain cancer. The treatment involves using a special type of immune cell called dendritic cells, which are loaded with pieces of the patient's own tumor to help the body recognize and attack any remaining cancer cells. The researchers want to see how well this treatment is tolerated and whether it can help patients live longer without their cancer getting worse.

To be eligible for this trial, participants must be between 18 and 70 years old, have recently been diagnosed with GBM, and have had surgery to remove most of the tumor. They should also have a certain level of health (measured by a score called Karnofsky Performance Status) and must be able to provide informed consent. Participants can expect to receive this new immunotherapy treatment along with standard treatments like chemotherapy and radiation. The trial is currently recruiting participants, and it's important to note that those with certain health conditions or who are pregnant cannot join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years and ≤70 years.
• • Postoperative Karnofsky Performance Status ≥70.
• • First diagnosis of GBM (World Health Organization \[WHO\] grade IV astrocytoma).
• • Diagnosis confirmed by the reference histopathology.
• • Residual tumor volume after resection \<10 cc, confirmed by postoperative MRI assessment
• • Total or subtotal resection of tumor mass, confirmed by assessment of the neurosurgeon and by postoperative radiological assessment.
• • Amount of non-necrotic tissue for lysate preparation and DC loading ≥1 gr, stored at -80°C.
• • Corticosteroids daily dose ≤4 mg during the 2 days prior to leukapheresis.
• • Clinical indication for radiochemotherapy according to the Stupp protocol (Stupp et al., 2005).
• • Life expectancy \> 3 months.
• • Informed consent
• Exclusion Criteria:
• • Pregnancy.
• • Participation in other clinical trials with experimental drugs simultaneously or within 1 month before this trial entry.
• • Presence of acute infection requiring active treatment.
• • Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose.
• • Presence of sub-ependymal diffusion of the tumor.
• • Presence of multi-focal GBM lesions.
• • Haematology: leukocytes \< 3,000/μl, lymphocytes \< 500/μl, neutrophils \< 1,000/μl, hemoglobin \<9 g/100 ml, thrombocytes \< 100,000/μl one or two days prior to leukapheresis.
• • Documented immune deficiency.
• • Documented autoimmune disease.
• • Positive serology for HIV, HBs antigen, HCV, TPHA.
• • Allergies to any component of the DC vaccine.
• • Known intolerance to TMZ.
• • Other active malignancy.