Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT00514046|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2007
Last Update Posted : December 20, 2017
- 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 (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.
- 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 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.
-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).
- 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 (MRI, 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.
|Condition or disease||Intervention/treatment||Phase|
|Medullary Thyroid Carcinoma Multiple Endocrine Neoplasia Type 2A Multiple Endocrine Neoplasia Type 2B||Drug: Vandetanib||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Vandetanib (ZD6474, ZACTIMA) in Children and Adolescents With Hereditary Medullary Thyroid Carcinoma|
|Study Start Date :||July 10, 2007|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||July 27, 2020|
vandetanib daily X 28 days
once daily continuously (28 day cycles)
- MTD [ Time Frame: after 4 weeks of drug ]Safety
- Objective response (CR or PR) [ Time Frame: every odd cycle ]Efficacy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514046
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Brigitte C Widemann, M.D.||National Cancer Institute (NCI)|