Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
Status:
Completed
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
Summary
Background:
- Medullary thyroid carcinoma (MTC) is common in people with a genetic disorder called
multiple endocrine neoplasia (MEN).
- Vandetanib is an experimental drug that blocks a defective protein receptor (rearranged
during transfection (RET) receptor) found on the surface of cancer cells in people with
MEN. It is thought that this protein is a primary cause of MTC in people with MEN.
Objectives:
- To study the activity of Vandetanib in children and adolescents with MEN-related MTC by
measuring the change in tumor size, in blood levels of proteins produced the tumor
(calcitonin and carcinoembryonic antigen (CEA) and in tumor-related diarrhea.
- To determine the safety and tolerability of Vandetanib in children and adolescents.
- To study how the body handles Vandetanib in children and adolescents.
- To determine the effect of Vandetanib on the survival of children and adolescents with
MTC.
Eligibility:
-Children and adolescents 5 to 18 years of age with MTC whose tumor cannot be surgically
removed or has grown back after treatment or has metastasized (spread beyond the thyroid
gland).
Design:
- Patients take Vandetanib once a day in 28-day cycles. The first patients enrolled in the
study are started on a low dose of Vandetanib to determine tolerability.
- Patients have periodic blood tests, electrocardiograms, and blood pressure measurements
to look for side effects of Vandetanib.
- Blood tests and imaging scans (magnetic resonance imaging (MRI), computed tomography
(CT), bone and octreoscan) are done every 8 weeks for the first 32 weeks of treatment
and then every 16 weeks for the duration of the treatment period.
- Patients who have tumor-related diarrhea keep a daily record of the number and
consistency of bowel movements.