Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
Status:
Completed
Trial end date:
2019-12-10
Target enrollment:
Participant gender:
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.