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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00514046 |
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and best dose of vandetanib and to see how well it works in treating patients with medullary thyroid cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer Multiple Endocrine Neoplasia 1 and 2 (men1, men2) |
Drug: vandetanib Procedure: comparative genomic hybridization Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: liquid chromatography Procedure: mass spectrometry Procedure: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | Phase I/II Trial of Vandetanib (ZD6474, ZACTIMA) in Children and Adolescents With Hereditary Medullary Thyroid Carcinoma |
Estimated Enrollment: | 21 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to age (13 to 18 vs 5 to 12).
Patients receive oral vandetanib once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected from patients periodically for pharmacokinetic, and biological studies, including analysis for concentrations of vandetanib, calcitonin, and CEA by liquid chromatography with tandem mass spectrometry (LC-MS/MS). Previously archived tumor tissue samples are analyzed for RET, VEGFR, EGFR, and somatostatin receptor by IHC and for secondary genetic changes (chromosomal gains/losses of DNA) by comparative genomic hybridization.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 5 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed medullary thyroid carcinoma meeting the following criteria:
Measurable disease, defined by RECIST as at least one lesion that can be accurately measured in at least one dimension with longest diameter of at least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
Inclusion criteria:
Creatinine clearance ≥ 60 mL/min OR age-adjusted serum creatinine according to the following schedule:
Must be able to take one of the oral formulations of vandetanib
Exclusion criteria:
Serum potassium < 3.5 mEq/L OR serum calcium or magnesium below the lower limits of normal
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Samuel A. Wells, MD, FACS 314-454-1898 |
Principal Investigator: | Frank M. Balis, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000559838, NCI-07-C-0189 |
Study First Received: | August 8, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00514046 |
Health Authority: | Unspecified |
recurrent thyroid cancer thyroid gland medullary carcinoma multiple endocrine neoplasia 1 and 2 (MEN1, MEN2) |
Carcinoma, Medullary Thyroid Neoplasms Endocrine System Diseases Recurrence Carcinoma Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |
Head and Neck Neoplasms Thyroid cancer, medullary Multiple Endocrine Neoplasia Endocrinopathy Thyroid Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms, Multiple Primary |