Study to evaluate the potentiation effect of radiotherapy by AGuIX nanoparticles for the treatment of persistent glioblastoma

Phase 1

• Conditions: Persistent Glioblastoma Multiforme, grade IV; MedDRA version: 20.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003774-32-IT
• Lead Sponsor: DIPARTIMENTO BIOMEDICINA E PREVENZIONE UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-02
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients who have previously a partial resection, biopsy or radiological diagnosis of Glioblastoma multiforme (GBM, WHO grade IV).
2.Not fit for Standard RT (60Gy/30 fractions over 6 weeks) in combination with Temozolomide
3.Patient’s age > 18 yo
4.Life expectancy = 3 months
5.Liver function (GGT, PAL, ASAT, ALAT, bilirubin) <1.5 times the upper normal limit
6.For patients receiving treatment with corticosteroids, treatment with corticosteroids must be at a stable or decreasing dose for at least 14 days before inclusion
7.Patient able to swallow and retain oral medication
8.Patients who have not received prior CHT or RT
9.Adequate renal function with standardized creatinine clearance = 50ml/min/1.73m²
10.Adequate hematological and hepatic functions: Platelet count > 100x10(9)/L (100,000 cells/mm3), Absolute granulocyte count (AGC) > 1.5 x 10(9)/L (1.500 cells/mm3), total serum bilirubin < 1.5 times the upper limit of normal, ALT (GPT) < 2.5 times the upper limit of normal and/or AST <2.5 times upper limit of normal.
11.Patient is able and willing to complete the quality-of-life questionnaires in Italian or any other official language into which the questionnaire is required to be translated. The baseline assessment must have already been completed.
12.Negative serum pregnancy test within 7 days before the first administration of treatment for women.
13.Women of childbearing potential and men whose partners are of childbearing potential must agree to use, themselves or their partners, an approved method of contraception throughout the treatment and at least 6 months after the last administration of study treatment.
14.Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee 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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Patients unable to undergo or tolerate MRI
2.Patients with contra-indication, sensitivity, or allergy to gadolinium or gadolinium-based contrast agents
3.Patients who have previously received brain irradiation
4.Patients with negative MRI within 72 hours after surgery
5.Age <18 yo
6.Standardized creatinine clearance < 50ml/min/1.73m²
7.History of nephropathy
8.Patients with, serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment or with any condition that does not permit compliance with the protocol
9.Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide.
10.Patients with known contra-indication, sensitivity or allergy to gadolinium
11.Patients unable to undergo or tolerate Magnetic Resonance Imaging or with known contra-indication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements or certain metal implants).
12.Pregnancy or breastfeeding
13.Subject under administrative or judicial control
14.Psychological disorder or social or geographic reasons that may compromise medical monitoring of the trial or compliance with treatment

Study & Design

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