Protocol

ADV1217: A Phase 1 Study of MK-1775 (IND#116495) Concurrent with Local Radiation Therapy For The Treatment Of Newly Diagnosed Children With Diffuse Intrinsic Pontine Gliomas (ADVL1217)

Diseases

Brain Tumor : Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)

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


Eligibility criteria, among others, include:


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
Phone: (901) 595-2544
FAX: (901) 595-6211

For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.

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.