INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas

Completed · Phase 1

Conditions studied: Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, DIPG, High-grade Astrocytoma NOS, CNS Primary Tumor, NOS (Malignant Glioma)

In brief

This is a multicenter phase 1 trial of INCB7839 for children with recurrent or progressive high-grade gliomas, including, but not limited to, diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), after upfront therapy.

Key facts

Study ID

NCT04295759

Run by

Pediatric Brain Tumor Consortium

People needed

13

Starts

2020-07-27

Expected to finish

2024-12-01

Last updated by the study team

2026-01-05

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis:
• Patients with recurrent/progressive high-grade gliomas, as defined by progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid wean, electrolyte disturbances, sepsis, hyperglycemia, etc.), OR a ≥ 25% increase in the bi-dimensional measurement, taking as a reference the smallest disease measurement recorded since diagnosis utilizing the MRI sequence best demonstrating tumor, OR the appearance of a new/metastatic tumor lesion(s) since diagnosis.
• Eligible diagnoses include but are not limited to the following: diffuse intrinsic pontine glioma (DIPG), H3K27M-altered diffuse midline glioma (DMG), glioblastoma multiforme, anaplastic astrocytoma and anaplastic oligodendroglioma. Spinal cord tumors are eligible with pathologic confirmation of the above.
• Please note: Patients with a radiographically typical DIPG at diagnosis, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation.
• Patients with pontine lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of pontine glioma WHO II-IV.
• Patients with diffuse or multi-focal disease are eligible; patients with leptomeningeal spread are eligible.
• Age
• Patients must be ≥ 3 but ≤ 21 years of age at the time of enrollment.
• BSA
• Patients must have a BSA ≥ 0.70-2.50 m2 for dose 120 mg/m2/dose BID.
• Patients must have a BSA ≥ 0.55-2.80 m2 for dose 80 mg/m2/dose BID (Patients who have BSA 0.55-1.00 m2 will only receive 100 mg AM dose).
• Ability to Swallow
• Patients must be able to swallow tablets whole.
• Measurable disease
• Patients must have measurable disease in two dimensions on MRI to be eligible.
• Prior Therapy
• Patients must have failed at least 1 standard, tumor-directed treatment besides surgery and recovered from the acute treatment-related toxicities (defined as < Grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment on this study.
• Patients must be ≥ 28 days from any prior surgery at the time of study enrollment (with the exception of minor dental and dermatological procedures).
• Chemotherapy
• Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea.
• Investigational/ Biologic Agent
• Biologic or investigational agent (anti-neoplastic): Patients must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.
• For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
• Monoclonal antibody treatment and agents with known prolonged half-lives: Patients must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to study enrollment.
• Immunotherapies: Patients who have received checkpoint inhibitors or other immunotherapies with a known potential for pseudoprogression and who have assumed tumor progression must be at least 12 weeks from prior immunotherapy AND have at least two MRI scans at least 4 weeks apart demonstrating further progression OR have a biopsy to confirm tumor progression OR have new site(s) of disease.

You may not qualify if…

• Pregnancy or Breast-feeding
• Pregnant women or nursing mothers are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Pregnant or breast-feeding women are excluded from this study due to risks of fetal and teratogenic adverse events as seen in animal studies.
• Concurrent Illness
• Patients with any clinically significant unrelated systemic illness (e.g., serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
• Patients with any other current malignancy.
• Patients with uncontrolled hypertension (i.e., a blood pressure (BP) > 95th percentile for age, height, and gender; patients with values above these levels must have their blood pressure controlled with medication prior to starting study drug).
• The normal blood pressure by height, age, and gender tables can be accessed in the Generic Forms section of the PBTC member's webpage.
• Patients who are ≥ 18 years of age must have blood pressure that is < 140/90 mm of Hg at the time of registration.
• Concomitant Medications
• Patients who are receiving any other anti-cancer, investigational or alternative (e.g., cannabinoids) drug therapy are ineligible.
• Prisoners
• Prisoners will be excluded from this study.
• Inability to participate
• Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures and study restrictions.
• Allergy
• Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition.
• Patients with a history of allergy to pork products due to contraindications with low molecular weight heparin (LMWH).
• Thrombosis Risk
• Patients with a known coagulopathy or bleeding disorder (e.g., von Willebrands disease) are not eligible.
• Patients with a history of non-central line related thrombosis or disorders that promote clotting (e.g., anti-thrombin III deficiency, Lupus anticoagulant) are not eligible.
• Significant family history of thrombosis (i.e. deep venous thrombosis or pulmonary embolus) in a first-degree relatives (i.e., parents or siblings) are not eligible.
• Estrogen containing contraceptives are not permitted due to thrombotic risk. Progestin-only contraception along with alternate forms of contraception are acceptable.
• Patients should be counseled to avoid smoking/tobacco products.
• If there is any contraindication to DVT prophylaxis, the patient is not eligible.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Stanford University and Lucile Packard Children's Hospital — Palo Alto, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cincinnati Children Hospital Medical Center — Cincinnati, Ohio, United States
• Children Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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