ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
Sabine Mueller, MD, PhD
Study ID
NCT04732065
Phase
PHASE1
Status
Recruiting
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Conditions

  • CNS Tumor
  • Central Nervous System Tumor
  • Diffuse Midline Glioma (DMG)
  • Glioblastoma
  • Recurrent Ependymoma
  • Recurrent Malignant Central Nervous System Neoplasm
  • Spinal Cord Glioma
  • World Health Organization (WHO) Grade III Glioma

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • ONC206 — DRUG
    Given orally (PO)
  • Standard of Care Radiation Therapy — RADIATION
    Undergo RT
  • Optional Proton (1H) MR spectroscopy (MRS) — PROCEDURE
    Optional imaging procedure

Study Details

This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.

Key Dates

Start date
Aug 23, 2021
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
208 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: ONC206 for participants with diffuse midline gliomas + prior therapy
    Participants receive ONC206 orally (PO) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. In case the participant receives clinical benefit from the treatment, treatment can proceed up to 24 months.
  • Experimental: Arm B: ONC206 + radiation therapy for newly diagnosed participants
    Participants undergo standard of care radiation therapy daily 5 days a week and receive ONC206 PO up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. In case the participant receives clinical benefit from the treatment, treatment can proceed up to 24 months.
  • Experimental: Arm C: ONC206 + radiation therapy, DMGs with evidence of first progression but previously untreated
    Participants undergo standard of care radiation therapy daily 5 days a week and receive ONC206 PO up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. In case the participant receives clinical benefit from the treatment, treatment can proceed up to 24 months.
  • Experimental: Arm D: ONC206 Therapy, Primary malignant CNS tumors with progression
    Participants receive ONC206 PO once a day (QD) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. In case the participant receives clinical benefit from the treatment, treatment can proceed up to 24 months.

Primary Outcome Measure

Proportion of participants with dose-limiting toxicities (DLT) [ Time Frame: Within 4 weeks after first dose ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
PNOC Operations
[email protected]
415-502-1600
[email protected]
Sabine Mueller, MD, PhD (PRINCIPAL_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20010
Lindsay Kilburn, MD
[email protected]
202-476-2800
Lindsay Kilburn, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Tobey MacDonald, MD
[email protected]
University of MichiganAnn ArborMichigan48109
Carl Koschmann, MD
[email protected]
Andrea Franson, MD
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Cassie Kline, MD
[email protected]
215-590-2299
Cassie Kline, MD (PRINCIPAL_INVESTIGATOR)

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