10015 A Non-Randomized, Open-Label, Phase 2 Study of Trametinib in Patients with Unresectable or Metastatic Epithelioid Hemangioendothelioma
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test any good and bad effects of the study drug called trametinib in people with EHE.
You/your child may be eligible because you/your child have epithelioid hemangioendothelioma (also called EHE), a rare type of cancer that is thought to develop from blood vessel cells. You/your child may be able to participate in this study because your EHE has spread to a different part of the body from the location in which it started or involves multiple places in your body or cannot be completely removed by surgery (is unresectable). Additionally, the cancer is growing or is causing severe pain that is being treated with a narcotic pain reliever.
All study participants will get the study drug trametinib. The study drug is provided in tablets and is taken every day of each cycle. A cycle is 28 days (4 weeks) of treatment. In the first part of the study, 13 patients with EHE will be enrolled and treated with trametinib. If the cancer shrinks by 30% or more in at least 1 of the patients, the study will enroll up to 14 more patients with EHE. The study drug (trametinib) is a pill taken by mouth once daily. It must be taken while fasting (no food; but water is permitted) either one hour before or two hours after a meal once daily. A Study Drug Diary will provide other information about how to take and record use of the study drug. Group 1: The first 13 participants will be the first to have received trametinib for this indication. Group 2: The next 14 participants will take part only if at least one response to the study drug is observed in the first group in the study. The study doctor will inform you if you are in the first or second group of participants.You/your child will receive the study drug until there is evidence of disease progression (cancer growth), or you/your child develop side effects that are not tolerable. If the EHE is not growing or is shrinking, you/your child will be able to continue the study treatment for up to four years. After 4 years, the study treatment will end. After you/your child finish the study drug, your doctor will continue to follow your condition by clinic visits at the study site, contacting your local doctor or contacting you by phone every 3 months for 6 months after you stop the treatment or for 2 years after enrolling in the study, whichever is longer.
03/05/2019 05:03 AM