Recruiting PHASE1, PHASE2 Malignant Glioma

New treatment option for Malignant Glioma

Official title A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

ClinicalTrials.gov ID: NCT05099003

What this study is testing

What is Selinexor?

Selinexor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant glioma.

Also referred to as ATG-010, CRM1 Nuclear Export Inhibitor KPT-330.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population.

Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 to 21

You may be able to join if

PRE ENROLLMENT: Patients must be =\< 25 years of age at the time of enrollment on APEC14B1 part A central nervous system (CNS)/high grade glioma...
Please note:
This required age range applies to pre-enrollment eligibility for all HGG patients. Individual treatment protocols may have different age criteria.
Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are \>= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).
PRE ENROLLMENT: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional...

You likely can't join if

STEP 1: Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid...
STEP 1: Patients who are currently receiving another investigational drug are not eligible.
STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible.
STEP 1: Patients \>=18 years of age who have H3 K27M-wild type HGG.
STEP 1: Patients who have an uncontrolled infection.
STEP 1: Patients who have received a prior solid organ transplantation.

See the full eligibility criteria

Who can join

PRE ENROLLMENT: Patients must be =\< 25 years of age at the time of enrollment on APEC14B1 part A central nervous system (CNS)/high grade glioma (HGG) pre-enrollment eligibility screening
Please note:
This required age range applies to pre-enrollment eligibility for all HGG patients. Individual treatment protocols may have different age criteria.
Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are \>= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).
PRE ENROLLMENT: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG
Please note: there are specific radiographic criteria for DIPG patient enrollment on ACNS1821 (Step 1)
As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
PRE ENROLLMENT:
For patients with non-pontine tumors: Patients and/or their parents or legal guardians must have signed informed consent for eligibility screening on APEC14B1 Part A.
For patients with DIPG: Patients and/or their parents or legal guardians must have signed informed consent for ACNS1821.
Note: As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
PRE ENROLLMENT:
For patients with non-pontine tumors only, the specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 ASAP, preferably within 5 calendar days of definitive surgery
STEP 1: Patients must be \>= 12 months and =\< 21 years of age at the time of enrollment
STEP 1: Patients must have newly-diagnosed DIPG or HGG (including DMG).
STEP 1: Stratum DIPG (Closed with Amendment #4)
As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
Patients with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2/3 of the pons on at least 1 axial T2 weighted image, are eligible. No histologic confirmation...
Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2/3 of the pontine cross-sectional area with or without extrapontine extension) are...
STEP 1: Stratum DMG (with H3 K27M mutation) (Closed with Amendment #4)
As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
Patients must have newly-diagnosed non-pontine H3 K27M-mutant HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1
Note: Patients need not have either measurable or evaluable disease, i.e., DMG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment. For rare H3...
STEP 1: Stratum HGG (without H3 K27M mutation)
Patients must have newly-diagnosed non-pontine H3 K27M-wild type HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1
Please note:
Patients who fall in this category and who are \>= 18 years of age are not eligible due to another standard-of-care regimen (radiation/temozolomide) that is available
Patients need not have either measurable or evaluable disease, i.e., HGG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment
STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\<16 years of age...
STEP 1: Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to step 1 enrollment)
STEP 1: Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to step 1 enrollment)
STEP 1: Hemoglobin \>= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to step 1 enrollment)
STEP 1: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to step 1 enrollment) or A serum creatinine based on age/sex as follows (within 7 days prior to...
Age / Maximum Serum Creatinine (mg/dL)
1 to \< 2 years / male: 0.6; female: 0.6
2 to \< 6 years / male: 0.8; female: 0.8
6 to \< 10 years / male: 1; female: 1
10 to \< 13 years / male: 1.2; female: 1.2
13 to \< 16 years / male: 1.5; female: 1.4
\>= 16 years / male: 1.7; female: 1.4
STEP 1: Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
STEP 1: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =\< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
STEP 1: Serum amylase =\< 1.5 x ULN
STEP 1: Serum lipase =\< 1.5 x ULN
STEP 1: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination.
STEP 1: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
STEP 1: Patients must be enrolled and protocol therapy must begin no later than 31 days after the date of radiographic diagnosis (in the case of non-biopsied DIPG patients only) or definitive surgery, whichever is the...

What rules you out

STEP 1: Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid medications.
STEP 1: Patients who are currently receiving another investigational drug are not eligible.
STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible.
STEP 1: Patients \>=18 years of age who have H3 K27M-wild type HGG.
STEP 1: Patients who have an uncontrolled infection.
STEP 1: Patients who have received a prior solid organ transplantation.
STEP 1: Patients with grade \> 1 extrapyramidal movement disorder.
STEP 1: Patients with known macular degeneration, uncontrolled glaucoma, or cataracts.
STEP 1: Patients with metastatic disease are not eligible; MRI of spine with and without contrast must be performed if metastatic disease is suspected by the treating physician.
STEP 1: Patients with gliomatosis cerebri type 1 or 2 are not eligible, with the exception of H3 K27M-mutant bithalamic tumors.
STEP 1: Patients who are not able to receive protocol specified radiation therapy.
STEP 1:
Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.
Lactating females are not eligible unless they have agreed not to breastfeed their infants. It is not known whether selinexor is excreted in human milk.
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
Sexually active patients of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control (including a medically accepted barrier method of contraception, e.g., male or...

The study team makes the final eligibility decision.

Where it's taking place

Birmingham, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oakland, California, United States
Orange, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Wilmington, Delaware, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States

+ 91 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 months to 21 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Loma Linda, California, United States; Long Beach, California, United States and 105 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.