A Phase I Study of MK-1775 with Radiation Therapy and Temozolomide in Patients with Newly Diagnosed Glioblastoma

Protocol
13-161
Full Title
Phase I Study of MK-1775 with Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma and Evaluation of Intratumoral Drug Distribution in Patients with Recurrent Glioblastoma (ABTC# 1202)
Phase
I
Disease Status
Newly Diagnosed
Purpose

Temozolomide is a standard treatment for an aggressive type of brain cancer called glioblastoma. However, this type of cancer is challenging to treat and usually continues to grow despite surgery, chemotherapy, and radiation therapy.

In this study, researchers want to find the optimal dose of an investigational drug called MK-1775 which can be given in combination with temozolomide and radiation therapy in patients newly diagnosed with glioblastoma. MK-1775 works by inhibiting an enzyme called Wee, which is very active in glioblastoma and can make the tumor resistant to radiation therapy. It is also hoped that MK-1775 will make the cancer cells more vulnerable to temozolomide.

Patients will be placed in one of two groups. In one group (Arm 1), researchers will determine the highest dose of MK-1775 that can be given safely with temozolomide taken daily during the six-week course of radiation therapy. In the second group (Arm 2), researchers will determine the highest dose of MK-1775 that can be given safely with temozolomide for five days out of every four weeks following the completion of radiation therapy.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with glioblastoma.
  • Patients in Arm 1 may not have received any prior therapy for glioblastoma.
  • Patients in Arm 2 should have received radiation therapy with temozolomide at least four weeks but no more than 49 days before starting treatment on this study, but no other previous treatment such as chemotherapy, immunotherapy, or biologic therapy.
  • Patients who have had prior treatment must have recovered from any serious side effects before entering the study.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 212-639-6767.

Disease(s)
Brain Tumors, Primary: Gliomas
Locations
Related Diseases