GlioblastomaPhase 2NCT06297512
Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).
A Phase 2 study testing Radiotherapy, Temozolomide, Doxorubicin in people with Glioblastoma, run by Iacopo Sardi at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 30 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Radiotherapy, Temozolomide, Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2022to 9 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Iacopo Sardi, iacopo.sardi@meyer.it
About this study
Official 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).
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
- Conditions
- Glioblastoma
- Being tested
- Radiotherapy, Temozolomide, Doxorubicin
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy, Temozolomide, DoxorubicinDrug
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);
| Study group | Role | What they receive |
|---|---|---|
| pGBM patients therapy | Experimental | * Whole therapy radiation therapy
* Temozolomide concomitant
* After 1 month adjuvant Temozolomide,
* After 3 months Doxorubicine
* adjuvant Temozolomide Receives: Drug: Radiotherapy, Temozolomide, Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation prolonged Dox
Time to early withdrawal from experimental treatment with Dox
Measured: through study completion, an average of 1 year
Percentage of Withdrawal from the study rate
Percentage of subjects with SAE leading to withdrawal from the study
Measured: through study completion, an average of 1 year
Percentage of SAEs
Percentage of SAEs
Measured: through study completion, an average of 1 year
Mortality rate
Mortality from adverse events
Measured: through study completion, an average of 1 year
Early discontinuation of dox treatment rate
Proportion of early discontinuation of experimental treatment with Dox
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Event-free survival (EFS), disease progression (PFS), and overall survival (OS)
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start9 Dec 2022
- Primary completion9 Nov 2027 (estimated)
- Study completion9 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iacopo Sardi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iacopo Sardi, Meyer Children's Hospital IRCCS
- Investigators
- Iacopo Sardi, Principal investigator, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297512
- Sponsor's protocol ID
- pGBM-WBRT/DOX2020
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT06297512
- Acronym / sponsor ID
- pGBM-WBRT/DOX2020
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Iacopo SardiUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 9 Nov 2027 (estimated)
- Study completion
- 9 Mar 2028 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pGBM patients therapy | Experimental | Drug: Radiotherapy, Temozolomide, Doxorubicin* Whole therapy radiation therapy * Temozolomide concomitant * After 1 month adjuvant Temozolomide, * After 3 months Doxorubicine * adjuvant Temozolomide |
Who may qualify
- Ages
- 3 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy, Temozolomide, DoxorubicinRadiation 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); | Drug | pGBM patients therapy |
Primary outcome
Evaluation prolonged Dox
Time frame: through study completion, an average of 1 year
Time to early withdrawal from experimental treatment with Dox
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
Percentage of SAEs
Time frame: through study completion, an average of 1 year
Percentage of SAEs
Mortality rate
Time frame: through study completion, an average of 1 year
Mortality from adverse events
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
1 secondary outcome
Event-free survival (EFS), disease progression (PFS), and overall survival (OS)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iacopo Sardi principal investigator
Meyer Children's Hospital IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Temozolomide, Doxorubicin in people with Glioblastoma, run by Iacopo Sardi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iacopo Sardi (0555662631, iacopo.sardi@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation prolonged Dox (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.