ADVL1217 - A Phase 1 Study of MK-1775 Concurrent with Local Radiation Therapy

ADVL1217 - A Phase 1 Study of MK-1775 Concurrent with Local Radiation Therapy for the Treatment of Newly Diagnosed Children with Diffuse Intrinsic Pontine Gliomas

Diseases

Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs). Patients with disseminated disease are not eligible.

Description

MK-1775 is an oral selective Wee1 kinase inhibitor. Wee1 is highly expressed in pediatric high-grade gliomas, including diffuse intrinsic pontine gliomas and studies have shown that the combination of Wee1 inhibitor MK-1775 radiosensitizes pediatric glioma cells. This is a dose escalation study of MK-1775 combined with standard radiation therapy. Patients will receive radiation Monday-Friday for 6 weeks and MK-1775 will be administered orally following radiation on certain days, depending on the assigned dose level.

Eligibility

  • Patients must be between 3 and 21 years of age and have a BSA greater than 0.35 m2.
  • Patients must not have received any prior chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant for the treatment of DIPG. Prior dexamethasone and/or surgery are allowed.
  • Must have adequate organ function as evidenced by laboratory criteria.
  • Patients with a seizure disorder may be enrolled only if on non-enzyme inducing anticonvulsants and seizures are well controlled.
  • Must not be receiving drugs that are strong or moderate inhibitors and/or inducers of CYP3A4 or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range, with the exception of corticosteroids.
  • Must be able to swallow capsules. Nasogastric or G tube administration is not allowed.
  • Must not have received a prior solid organ transplantation.

  • Contact

    For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur,RN, MSN, CPNP, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at kamazur@txch.org.