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JOURNAL ONKOLOGIE – STUDIE

Targeted Pediatric High-Grade Glioma Therapy

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NCT-Nummer:
NCT05839379

Studienbeginn:
Juni 2024

Letztes Update:
21.06.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma, Glioma, Astrocytoma, Diffuse Intrinsic Pontine Glioma

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
Nationwide Children's Hospital

Collaborator:
-

Studienleiter

Maryam Fouladi, MD
Study Chair
Nationwide Children's Hospital
Margot Lazow, MD
Study Director
Nationwide Children's Hospital

Kontakt

Studienlocations
(3 von 18)

Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
69120 Heidelberg
(Baden-Württemberg)
Germany» Google-Maps
Ansprechpartner:
Olaf Witt, MD
Phone: 0496221423570
E-Mail: o.witt@kitz-heidelberg.de» Ansprechpartner anzeigen
Cincinnati Children's Hospital Medical Center
45229 Cincinnati
United States» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

A novel, molecularly-guided, multi-arm phase umbrella II trial is proposed in children,

adolescents, and young adults with newly diagnosed HGG, including DIPG, in which we will (1)

conduct comprehensive molecular screening of tumor tissue using a multi-omic approach

(WES/WGS, gene fusion panels/RNASeq, DNA methylation microarray) across international CONNECT

genomics cores with rapid return of clinical results, (2) stratify patients to

biologically-targeted treatment arms, based on the tumor molecular profile and

histopathology, and (3) perform longitudinal evaluation of peripheral blood, cerebrospinal

fluid (CSF), and/or tumor tissue as well as advanced neuro-imaging to determine genomic,

immune, and radiologic biomarkers predictive of response, recurrence, resistance, and

toxicity.

Based on results of the above tumor molecular profiling and pathology-based confirmation of

HGG diagnosis, eligible patients will be assigned to one of several biologically guided

treatment arms on a phase II trial.

Approximately 400-450 patients will be enrolled on the screening protocol through which

biospecimens (paired tumor DNA/RNA and normal comparator samples) will undergo extensive

molecular profiling to assess eligibility to any of the therapeutic subprotocols of the phase

II study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Age: Patients must be ≥12 months and ≤30 years of age at the time of enrollment onto

this screening protocol.

2. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. The

diagnosis of HGG must have been confirmed by local pathology review. for the diagnosis

of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of

at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4

glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered

diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.

3. Disease Status: There are no disease status requirements for enrollment.

- Measurable disease is not required. Patients without measurable disease are

eligible.

- Patients with metastatic/disseminated or multifocal disease or gliomatosis

cerebri are eligible.

- Patients with a primary spinal tumor are eligible.

- Patients with secondary, radiation related HGG are eligible.

4. Prior Therapy for HGG: Surgery, radiation, and/or dexamethasone are permissible.

Temozolomide concurrent with radiation is permissible, but not recommended. No other

prior anticancer therapy for HGG will be allowed.

Timing from surgery to start of RT: For patients who have started RT, radiation must

have started within 31 days of definitive surgery or biopsy (if patient had two

surgeries, radiation must have started within 31 days from second surgery).

5. Tumor Sample Availability OR results from previous molecular profiling/targeted

sequencing

- If a patient screens through OPTION #1, tumor sample in addition to normal

comparator tissue (peripheral blood or saliva) must be submitted for

comprehensive molecular screening at the time of screening enrollment.

- If a patient screens through OPTIONS #2 or #3, results from previously performed

molecular profiling must be submitted following enrollment. It is highly

recommended that results be uploaded within 7 days of enrollment (if results are

available at time of enrollment) or within 7 days of results becoming available

(if pending at time of enrollment) to allow adequate time for central review.

6. Informed Consent: All patients and/or their parents or legally authorized

representatives must sign a written informed consent. Assent, when appropriate, will

be obtained according to institutional guidelines.

7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between

diagnosis and the following specific timepoints post completion of RT

- Patients screening through OPTION #1 are eligible to enroll anytime between

diagnosis and 10 days post RT.

- Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime

between diagnosis and 21 days post RT.

However, it is important to note the following:

- For treatment protocols that include targeted therapy administered concurrently with

RT, patients must start treatment within 10 calendar days of starting RT.

- For treatment protocols that only include maintenance/adjuvant therapy (no systemic

therapy given concurrently with radiation), patients must start treatment by 35 days

post RT

#SCREENING OPTIONS

- OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories

- OPTION2: Molecular screening through a national comprehensive tumor profiling program

- OPTION3: Clinically validated targeted sequencing or focused profiling

Exclusion Criteria:

-Tumors that do not meet HGG and DIPG diagnoses specified above

Studien-Rationale

Primary outcome:

1. Molecular profiling (Time Frame - 4 years):
Utilize molecular, clinical, and histopathologic data to assess eligibility for specific biologically-guided treatment subprotocols among pediatric, adolescent and young adult patients with newly diagnosed HGG, including DIPG.

2. Feasibility of molecular profiling and enrollment to a TarGeT treatment protocol (Time Frame - 4 years):
Determine the percent of pediatric, adolescent, and young adult patients newly diagnosed with HGG, including DIPG, who undergo comprehensive molecular characterization across clinical molecular testing laboratories at CONNECT sites and begin treatment on a TarGeT treatment subprotocol within 10 calendar days of starting radiation therapy (RT) (if treatment involves an agent given concurrently with RT) or within 35 days of completion of RT (if treatment involves adjuvant maintenance therapy).

Secondary outcome:

1. Genomic Research (Time Frame - 6 years):
Increase knowledge of the genomic and immunologic landscape of newly-diagnosed pediatric and young adult HGGs, including DIPG, through comprehensive molecular characterization.

2. Germline susceptibility testing (Time Frame - 4 years):
Determine the frequency and spectrum of germline cancer susceptibility mutations in children and young adults with HGG and DIPG and assess the feasibility of return of those results.

3. Biobanking (Time Frame - 4 years):
Prospectively collect tumor tissue from diagnostic biopsy/resection as well as baseline peripheral blood and cerebrospinal fluid (CSF) samples for the CONNECT biorepository to be used in correlative research for the present trial as well as future studies.

Quelle: ClinicalTrials.gov


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