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Phase 1

• Conditions: Glioblastoma is the most common primary brain tumour in humans withthe most severe prognosis. Standard treatments consist primarily ofsurgery in order to debulk thetumoral mass, as well asradiochemotherapy to induce optimal local tumor control. However themedian overall survival (OS)is about 15 months, with 88% of patientsdead within 3 years; MedDRA version: 18.0Level: HLTClassification code 10045172Term: Tumour vaccine therapiesSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005387-25-IT
• Lead Sponsor: Sapienza, University of Rome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-07
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1.Primary or recurrent histologically confirmed GBM after surgery
2.Total or subtotal (at least 90%) resection of tumour mass, confirmed by assessment of neurosurgeon and postoperative magnetic resonance imaging (MRI) within 48 hours
3.Ages 18 to 70 years old
4.Postoperative Karnofsky Performance Status (KPS) =70
5.A life expectancy > 6 months
6.Adequate hematologic, renal and hepatic function
7.Fertile subjects must use acceptable birth control from screening until the last study visit or early termination. Acceptable methods of birth control include: spermicide with condom, diaphragm, or cervical cap, IUD (intrauterine device), hormonal contraception, vasectomy, and abstinence. (Plan B or the rhythm method are not considered reliable methods.)
8.Willing and able to provide written informed
9.Ability to comply with protocol requirements

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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1.Past or ongoing documented autoimmune diseases
2.HIV, syphilis, active HBV and HCV infection
3.Any medical disorder that would impair the ability to receive study treatment
4.Other active of in the past five years malignancies
5.Any unresolved chronic toxicity greater than Grade 2 (NCI-CTCAE version 4.03) from previous anticancer therapy (except alopecia)
6.Pregnant or breast feeding patients
7.Documented immune deficiency
8.Lymphodemia in the region to be vaccinated
9. Mandatory treatment with corticosteroids or salicylates in inflammatory dose

Study & Design

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