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NCT Number: NCT06297512

Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

3 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Meyer Children's Hospital IRCCS

Florence, Italy

Location status: Recruiting

Location contact

Iacopo Sardi

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histological-molecular diagnosis according to WHO 2016 classification: IDH-wildtype glioblastoma (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH-mutated glioblastoma (9445/3), glioblastoma NOS (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic or gliomatosis cerebri pictures of first diagnosis Not previously treated (with chemo and radiotherapy) or treated only surgically (total, near partial, partial, biopsy).
  • Males and females between the ages of 3 and 30 years old
  • Life expectancy ≥ 12 months
  • karnofsky/Lansky ≥ 80 %
  • Adequate hematologic function: Absolute leukocyte count ≥ 2.0 x 109/l, Hemoglobin ≥ 10 g/dl, Platelet count ≥ 50 x 109/l
  • Adequate liver function: Total bilirubin ≤ 2.5 x ULN, ALT/AST ≤ 5.0 x ULN
  • Adequate renal function:Serum creatinine ≤ 1.5 x ULN
  • Written informed consent from the patient, parents or legal guardians
  • Patient's willingness during treatment and ability to comply with the protocol

Exclusion criteria

  • Evidence of any other serious disease or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe syndromes congenital syndromes, heart disease)
  • Performance of a course of 1st-line chemotherapy at the same time as study initiation
  • Concurrent participation in other research projects
  • Pregnancy or lactation status
  • Use of inappropriate contraceptive methods

Treatment and study plan

Radiotherapy, Temozolomide, Doxorubicin

Drug

Radiation treatment Concomitant TMZ: 75mg/m2/day per OS for 7 days per week, from the first day of radiotherapy to the last (maximum cumulative dose 3150mg/m2), with possibility of earlier initiation on clinician's judgment.

After 1 month (4-5 weeks ± 7 days) from the end of RT/TMZ treatment they will receive:

Adjuvant TMZ: 2 cycles at increasing doses (150-180 mg/m2) per OS for 5 consecutive days 28 days apart

After 3 months (12 weeks ± 7 days) from the end of RT/TMZ treatment they will receive:

Dox 4 cycles with 37.5mg/m2/day by continuous infusion over 48 hours (2 days) every 28 days (maximum cumulative dose 300mg/m2)

And after 4 weeks ± 7 days from the end of Dox treatment they will receive:

TMZ adjuvant 12 cycles at increasing doses (150-180 mg/m2) by OS for 5 consecutive days 28 days apart (maximum cumulative dose 16200 mg/m2);

Primary outcomes

  1. Evaluation prolonged Dox

    Time frame: through study completion, an average of 1 year

    Time to early withdrawal from experimental treatment with Dox

  2. Percentage of Withdrawal from the study rate

    Time frame: through study completion, an average of 1 year

    Percentage of subjects with SAE leading to withdrawal from the study

  3. Percentage of SAEs

    Time frame: through study completion, an average of 1 year

    Percentage of SAEs

  4. Mortality rate

    Time frame: through study completion, an average of 1 year

    Mortality from adverse events

  5. Early discontinuation of dox treatment rate

    Time frame: through study completion, an average of 1 year

    Proportion of early discontinuation of experimental treatment with Dox

Secondary outcomes

  1. Event-free survival (EFS), disease progression (PFS), and overall survival (OS)

    Time frame: through study completion, an average of 1 year

    Event-free survival (EFS) calculated as the time between the date of enrolment and the date of occurrence of one of the events:

    • disease progression established according to the modified RANO criteria for paediatric age
    • clear progression of non-measurable lesions (T1);
    • - any new lesion;
    • clinical deterioration due to the tumour and not attributable to other causes (e.g, seizures, adverse drug effects, complications of therapy, cerebrovascular events infections and so on);
    • failure to return for evaluation following death (from any cause) or deterioration of condition;
    • and other described in the protocol

Study contacts

Contact information is provided by the study sponsor or research team.

Iacopo Sardi

CONTACT

[email protected]

0555662631

Sponsors and collaborators

Lead sponsor

Iacopo Sardi

Other

Registry information

Official study title

Interventional, Single-arm, Open-label Open-label, Phase II Trial to Evaluate the Role of Anthracycline Infusion After Radio Therapy (RT) in Pediatric and Young Adults With Glioblastoma (pGBM).

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 7, 2024
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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