Clinical trial to evaluate the effects of chemotherapy with anthracycline, after radiotherapy, in a group of pediatric and young adult patients with glioblastoma

Phase 1

• Conditions: First diagnosed glioblastoma; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005131-74-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with glioblastoma, first diagnosed not previously treated (with chemotherapy and radiotherapy) or treated only surgically
2. Males and females between the ages of 3 and 30
3. Life expectancy > or = 12 months
4. Karnofsky / Lansky > or = 80%
5. Adequate haematological function:
¿ Absolute white blood cell count >= 2.0 x 10^9 / l
¿ Hemoglobin >= 10 g / dl
¿ Platelet count >= 50 x 109 / l
6. Adequate liver function:
¿ Total bilirubin <= 2.5 x ULN
¿ ALT / AST <= 5.0 x ULN
7. Adequate renal function:
¿ Serum creatinine <= 1.5 x ULN
8. Written informed consent from the patient, parents or legal guardians
9. Patient availability during treatment and ability to comply with the protocol
Are the trial subjects under 18? yes
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 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Evidence of any other serious illness or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe congenital syndromes, heart disease)
2. Perform a 1st line chemotherapy cycle at the same time as the start of the study
3. Simultaneous participation in other research projects
4. State of pregnancy or breastfeeding
5. Use of inadequate contraceptive methods

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of prolonged administration of doxorubicin in combination with radiotherapy and temozolomide in pediatric and young adult patients with gliobastoma;Secondary Objective: Evaluate the effectiveness of treatment by determining event-free survival (EFS), disease progression (PFS), and overall survival (OS);Primary end point(s): The primary safety endpoint is defined as:<br>- Time to early discontinuation of the experimental treatment with Doxorubicin<br>- Percentage of subjects with Serious Adverse Events (SAE) that lead to withdrawal from the study<br>- Percentage of SAE <br>- Mortality due to adverse events<br>- Proportion of early discontinuation of the experimental treatment with Doxorubicin;Timepoint(s) of evaluation of this end point: Every 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints are:<br>1. Event-free survival (EFS) that is the time between the date of enrollment and the date of occurrence of one of the following events:<br>- disease progression established according to RECIST 1.1 criteria<br>- disease relapse<br>- all-cause mortality<br>2. Overall survival (OS) defined as the time between the date of enrollment and the date of death from any cause<br>3. Progression-free survival (PFS) defined as the time between the date of enrollment and the date of progression according to RECIST 1.1 criteria<br>4. Proportion of treatment responder (CR, complete responder; PR, partial responder; SD, stable disease; PD, disease progression) according to RECIST 1.1. criteria<br><br>In case of loss at follow-up, survival at the last available evaluation will be considered.;Timepoint(s) of evaluation of this end point: Every three months