Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT04002804
Eligibility Criteria:
Inclusion Criteria:
* Patients of both genders.
* Age 18 years and 70 years.
* Postoperative Karnofsky Performance Status \>=70.
* Diagnosis of recurrent GBM (World Health Organization \[WHO\] grade IV astrocytoma).
* Diagnosis confirmed by the reference histopathology.
* 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.
* Life expectancy \> 3 months.
* Signed 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.
* Haematology: leukocytes \< 3,000/μl, lymphocytes \< 500/μl, neutrophils \< 1,000/μl, hemoglobin \<9 g/100 ml, thrombocytes \< 100,000/μl 2 days prior to leukapheresis.
* Documented immune deficiency.
* Documented autoimmune disease.
* Positive serology for HIV or hepatitis B or C.
* Allergies to any component of the DC vaccine.
* Known intolerance to TMZ.
* Other active malignancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04002804
Study Brief:
Protocol Section:
NCT04002804