Clinical Trials

3 studies in Thyroid Cancer

1. Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer Jacksonville, FL Rochester, MN View Summary
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   Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.

   NCT ID:

   NCT01229865

   IRB Number:

   10-001281

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   Who can I contact for additional information about this study?

   Rochester: Keith Bible, MD 507-284-8440
                       
   
   Jacksonville: Robert Smallridge, MD 904-953-6824
                       
   

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2. Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer Rochester, MN View Summary
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   Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To determine the objective response rate to sorafenib tosylate (sorafenib) in children with relapsed or refractory rhabdomyosarcoma, Wilms tumor, hepatocellular carcinoma (HCC), or papillary thyroid carcinoma (PTC). SECONDARY OBJECTIVES: I. To further define and describe the toxicities of sorafenib administered on an oral, twice-daily continuous schedule. II. To further characterize the pharmacokinetics of sorafenib in children with refractory cancer. III. To estimate the progression-free survival on sorafenib for rhabdomyosarcoma, Wilms tumor, and hepatocellular carcinoma and compare to a group of patients enrolled on selected closed Phase II studies of Children Oncology Group (COG). IV. To assess the biologic activity of sorafenib on vascular endothelial growth factor (VEGF) and soluble vascular endothelial growth factor receptor-2 (VEGFR-2) in peripheral blood samples. (Exploratory) V. To evaluate the presence of BRAF mutations and RET/PTC rearrangements in patients with PTC. (Exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (rhabdomyosarcoma vs Wilms tumor vs hepatocellular carcinoma vs papillary thyroid carcinoma). Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for pharmacokinetic studies, and VEGF and VEGFR-2 analysis by ELISA. Previously collected formalin-fixed paraffin-embedded tissue samples, from patients with papillary thyroid carcinoma, are also analyzed for BRAF mutation and RET/PTC rearrangements by PCR. After completion of study treatment, patients are followed up for up to 5 years.

   NCT ID:

   NCT01502410

   IRB Number:

   12-001459

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   Who can I contact for additional information about this study?

   Rochester: Carola A. Arndt 507-538-7623
                       
   
   
   

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3. Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Jacksonville, FL Rochester, MN View Summary
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   Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. The objective response rate, defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy with cabozantinib (cabozantinib-s-malate). SECONDARY OBJECTIVES: I. To assess duration of objective response, progression-free survival and overall survival. II. To assess tolerability and adverse events of cabozantinib as a 2nd line therapy in patients with differentiated thyroid cancer (DTC). TERTIARY OBJECTIVES: I. To assess effect of cabozantinib on serum tumor marker thyroglobulin and its correlation with overall response rate. II. To assess response of cabozantinib in bone metastasis (bone metastasis-specific progression free survival) as evaluated by pre- and on-study functional imaging such as bone scan, fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET) scan and/or 18F sodium fluoride (NaF) PET scan. III. To assess effect of cabozantinib on serum and urinary markers of bone turnover and its correlation with response to bone metastasis. IV. To assess predictors of response by performing tumor genotype studies (e.g. BRAF, RAS, phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha [PIK3CA], mitogen-activated protein kinase 1 [MAP2K1], AKT1, mesenchymal-epithelial transition [MET], rearranged in transformation [RET]/papillary thyroid carcinoma [PTC] rearrangement) in archived tumor tissue. V. To assess predictors of response by assessing baseline expression levels of vascular endothelial growth factor (VEGF), phosphorylated vascular endothelial growth factor receptor (pVEGFR), protein kinase ribonucleic acid (RNA)-like endoplasmic reticulum kinase (pERK), pAKT and/or total MET by immunohistochemistry in archived tumor tissue. OUTLINE: Patients receive cabozantinib-s-malate orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks and then every 3 months for 1 year.

   NCT ID:

   NCT01811212

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   Who can I contact for additional information about this study?

   Rochester: Keith C. Bible 507-266-0029
                       
   
   Jacksonville: Robert C. Smallridge 904-953-2224
                       
   

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