TEMOZOLOMIDE for Glioblastoma|Glioblastoma multiforme

Inclusion criteria

• {"criterion_text":"- Must be at least 18 years and less than 70 years of age.\n- Must be ambulatory with a ECOG performance status 0 or 1\n- Must have histologically confirmed glioblastoma IDH wild type, with non-methylated MGMT-gene promotor, and a candidate for combined radiation therapy and chemotherapy (\"Stupps Regimen\").\n- Must have accessible volume and quality of tumor tissue for vaccine production (proliferation of cells and extraction of tumor mRNA).\n- Must have postoperative MRI after surgery with contrast enhancing tumor remnant of less than 1 cm3 or less than 10% of original tumor volume.\n- Normal organ function defined by laboratory values.\n- Serology indicating contagious HIV, HBV, HCV and Treponema pallidum must be negative.\n- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations."}

Exclusion criteria

• {"criterion_text":"- Tumor in a localization where a modest increase in size due to reactive edema may have a large impact on the patient's neurological condition, i.e. brain stem.\n- Positive pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose. Reliable methods of contraception are defined in section\n- Any reason why, in the opinion of the investigator, the patient should not participate.\n- History of prior malignancy other than glioblastoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.\n- Active infection requiring antibiotic therapy.\n- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.\n- Prior splenectomy.\n- Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.\n- Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.\n- History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.\n- Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination."}

Primary endpoints

• {"endpoint_text":"- Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months.","definition_or_measurement_approach":"Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression according to RANO criteria; objective tumor response assessed by MRI at start of vaccination, at week 25 and thereafter every 3 months."}
• {"endpoint_text":"- As contrast enhancement may vary over time, due to pseudoprogression and may be affected through the course of the immune-therapy, the definite time of progression may be corrected after overall survival has been reached.","definition_or_measurement_approach":"Acknowledges that time of progression may be corrected after overall survival has been reached due to possible pseudoprogression and immune-therapy effects on contrast enhancement."}

Norway

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

12-01-2026

Processing Time Days

451

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway