Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00514046|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2007
Last Update Posted : May 8, 2020
- 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|
|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|
|Actual Study Start Date :||July 20, 2007|
|Actual Primary Completion Date :||December 10, 2019|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: Arm 1
Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m2/d.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|