Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors

Summary

Background: -Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in one of their proteins called succinate dehydrogenase (SDH). Vandetanib is a cancer drug that has been approved to treat thyroid cancer and has been used with some success in other tumors that have a similar loss of SDH. Researchers want to see if this drug can also decrease tumor growth in people with WT-GIST. Objectives: -To test whether the study drug will benefit people with WT-GIST. Eligibility: -Adults and children 3 years old and older with WT-GIST. Design: * Researchers will test participants tumor tissue to confirm it is the wild type of GIST. * Participants will be screened with a medical history, physical exam, and blood tests. They will also have electrical recording of the heart (Eastern Cooperative Oncology Group (ECOG)) and scans of the tumor. * Participants will take the study drug in 28-day cycles. Their doctor will decide how many cycles they can complete. * They will take the study drug once every day and record it in a diary. * On Day 14, they will also visit their doctor to look for side effects. * Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood pressure check, and blood tests. These tests will then be done periodically for as long as they are in the study. * Before cycle 4, scans will be done to check the size of the cancer. Most of these will be repeated every 3-6 cycles. * When they stop taking the study drug, participants will return to the clinic for a physical exam and blood tests.

Timeline

Start

2013-12-14

Primary completion

2016-05-04

Completion

2019-12-10

Drugs

Indications