Study to evaluate the therapeutic effect of a cell based immune therapy targeting cancer stem cells i the malignant brain tumor glioblastoma.

Phase 1

• Conditions: Glioblastoma brain tumors; MedDRA version: 19.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002198-40-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-07
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All of the following conditions must apply:
1.Must be at least 18 years and less than 70 years of age.
2.Must be ambulatory with a ECOG performance status 0 or 1
3.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”).
4.Must have accessible volume and quality of tumor tissue for vaccine production (proliferation of cells and extraction of tumor mRNA).
5.Must have postoperative MRI after surgery with contrast enhancing tumor remnant of less than 1 cm3 or less than 10% of original tumor volume.
6.Normal organ function defined by laboratory values.
7.Glucocorticosteroids should be minimized or stopped before starting given vaccination.
8.Negative 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 8.8.
9.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Tumor in a localization where a modest increase in size due to reactive oedema may have a large impact on the patient’s neurological condition, i.e. brain stem.
2.Large tumor remnant.
3.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.
4.Active infection requiring antibiotic therapy.
5.Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
6.Prior splenectomy.
7.Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
8.Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
9.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.
10.Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination.
11.Any reason why, in the opinion of the investigator, the patient should not participate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified