NCT04801147CompletedPhase 1/2
Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme
Phase I Clinical Trial Of Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme (DENDR1)
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
Rationale of the Study: Treatment for GBM currently consists of surgical resection of the tumour mass followed by radio- and chemotherapy ((1)Stupp et al., 2005). Nonetheless overall prognosis still remains bleak, recurrence is universal, and recurrent GBM patients clearly need innovative therapies. Dendritic cells (DC) immunotherapy could represent a well-tolerated, long-term tumour-specific treatment to kill all (residual) tumour cells which infiltrate in the adjacent areas of the brain. Preclinical investigations for the development of therapeutic vaccines against high grade gliomas, based on the use of DC loaded with a mixture of glioma-derived tumor have been carried out in rat as well as in mouse models, showing the capacity to generate a glioma-specific immune response. Mature DC loaded with autologous tumor lysate have been used also for the treatment of patients with recurrent malignant brain tumors; no major adverse events have been registered. Results about the use of immunotherapy for GBM patients are encouraging, but further studies are necessary to find out the most effective and safe combination of immunotherapy with radio- and chemotherapy after exeresis of the tumour mass. Aim of the study. Primary objective of the study is to evaluate treatment tolerability and to get preliminary information about efficacy. Secondary objective is to evaluate the treatment effect on the immune response. Additional objective is to identify a possible correlation between methylation status of MGMT promoter and tumor response to treatment. A two-stage Simon design ((2)Simon, 1989) will be considered for the study. Assuming as outcome measure the percentage of PFS12 patients and of clinical interest an increase to 42% (P1) of the historical control rate of 27% (P0) ((1)Stupp et al., 2005), the alternative hypothesis will be rejected at the end of the first stage if the PFS12 rate will be less than 8/24 treated patients (Fisher's exact test). In the second stage patients will be enrolled up to 76 overall. The null hypothesis will be rejected (a=0.05, b=0.2) if at least 27 subjects out of 76 are alive and progression free 12 months after the beginning of the treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 9 Mar 2021
- Start date
- 26 Jun 2010
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Diseases
- Glioblastoma
- NCT number
- NCT04801147
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 76
- From 26 Jun 2010 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other clinical trials with experimental drugs simultaneously or within 1 month before this trial entry.
- Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose.
Other illness
- Presence of acute infection requiring active treatment.
- Documented autoimmune disease.
- Positive serology for HIV, HBs antigen, HCV, TPHA.
- Allergies to any component of the DC vaccine.
- Other active malignancy.
Lab values
- 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.
Other
- Pregnancy.
- Presence of sub-ependymal diffusion of the tumor.
- Presence of multi-focal GBM lesions.
- Documented immune deficiency.
- Known intolerance to TMZ.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UOC Neuro-oncologia Molecolare Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.