ADV1217: WEE1 Inhibitor MK-1775 and Local Radiation Therapy in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas

A Phase I Study of MK-1775 (IND#116459) Concurrent with Local Radiation Therapy for the Treatment of Newly Diagnosed Children with Diffuse Intrinsic Pontine Gliomas

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)

Eligibility Overview:

  • Participant is > 36 month and < 21 years of age at the time of study enrollment.
  • Participant has newly diagnosed DIPG.
  • Participant has a brainstem tumor that was biopsied and proven to be one of the following: anaplastic astrocytoma, glioblastoma, gliosarcoma, or anaplastic mixed glioma.
  • Participant has not received any prior chemotherapy, radiation therapy, immunotherapy or bone marrow transplant for the treatment of DIPG. Prior dexamethasone and/or surgery are allowed.

Description

This is called a Phase 1 study because the goal is to find the highest dose of MK-1775 that can be given safely in combination with radiation. It is not known if MK-1775 given with radiation therapy will work for this kind of brain tumor.

The drug, MK-1775, is an anti-cancer drug that is considered experimental because it has not yet been approved by the Food and Drug Administration (FDA) for the treatment of cancer. In this trial, MK-1775 is used in combination with radiation therapy because this combination was better than radiation treatment alone in test tubes and animal models of brain tumors. MK-1775 is also effective against other types of tumors in test tubes and animals. MK-1775 has been used in only a small number of adults and there is a lot not known about it yet. This study will be the first time that MK-1775 is given to children.

Different doses of the study drug MK-1775 will be given to several study participants. The first group of study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered. Then the study is stopped.

Objectives

  • To find the highest safe dose of MK-1775 that can be given together with radiation therapy without causing severe side effects;
  • To learn what kind of side effects can be caused by MK-1775 with radiation therapy;
  • To learn more about the pharmacology (how your body handles the drug) of MK-1775;
  • To learn more about the biology effects of MK-1775 on the cells in your body;
  • To determine whether MK-1775 with radiation therapy is a beneficial treatment for your tumor.

Eligibility criteria, among others, include:

  • Participant is > 36 month and 21 years of age at the time of study enrollment.
  • Participant has newly diagnosed DIPG, defined as tumor with a pontine epicenter and diffuse involvement of the pons. Histologic confirmation is not required.
  • Participant has a brainstem tumor that does not meet above criteria, but was biopsied and proven to be one of the following: anaplastic astrocytoma, glioblastoma, gliosarcoma, or anaplastic mixed glioma.
  • Enrollment is < 28 days after the date of radiographic diagnosis or surgery, whichever is the later date.
  • Participant has not received any prior chemotherapy, radiation therapy, immunotherapy or bone marrow transplant for the treatment of DIPG. Prior dexamethasone and/or surgery are allowed.

Contact

Alberto Broniscer, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Phone: 901-595-2544 or 901-595-4599
Fax: 901-595-6211

OR

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
MS 260
262 Danny Thomas Place
Memphis, TN 38105
Phone: (901) 595-2544
FAX: (901) 595-6211

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.