Status:
RECRUITING
Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 r...
Detailed Description
Background and significance. The therapeutic program will include radical surgical resection of the tumor, followed by radiotherapy (fractionated local field irradiation in daily fractions of 2 Gy giv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04801147
Start Date
June 26 2010
End Date
December 1 2024
Last Update
November 8 2024
Active Locations (1)
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1
UOC Neuro-oncologia Molecolare
Milan, Italy, 20133