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Vandetanib to Treat Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT01372813
Recruitment Status : Terminated (Terminated for insufficient accrual.)
First Posted : June 14, 2011
Results First Posted : March 12, 2012
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
W. Marston Linehan, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Clear Cell Renal Carcinoma
Intervention Drug: vandetanib
Enrollment 3

Recruitment Details Trial only accrued 3 participants.
Pre-assignment Details  
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
58.8  (5.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR))
Hide Description Clinical response is the best response recorded from the start of treatment until disease progression. Clinical response is assessed by the Response Evaluation in Solid Tumors (RECIST) criteria. A partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. A complete response (CR) is the disappearance of all target lesions.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: Participants
0
2.Secondary Outcome
Title Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2)
Hide Description Plasma VEGFR and VEGFR2 would have been measured using the (enzyme-linked immunosorbent assay)ELISA at baseline and specified timepoints following initiation of therapy.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not enough samples for meaningful analysis.
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Circulating Endothelial Progenitor Cells (CEP) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment
Hide Description CEP cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not enough samples for meaningful analysis.
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Hide Description

Progression free survival is defined as the time from initiation of treatment to either progression or death.

RECIST evaluates tumor response. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For detailed information about RECIST, see the protocol Link module.

Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 3
Median (95% Confidence Interval)
Unit of Measure: Days
55
(51 to 111)
5.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 11.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: Participants
3
6.Secondary Outcome
Title Number of Circulating Endothelial Cells (CEC) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment
Hide Description CEC cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not enough samples for meaningful analysis.
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)
Hide Description Flow dynamics within specific tumor sites will be evaluated based on the results of the DCE-MRI obtained first without contrast enhancement and then after contrast enhancement. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters previously defined (Ktrans, Kep, etc.).
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants with changes
0
8.Secondary Outcome
Title Tumor Tissue Used to Evaluate Von Hippel-Lindau (VHL) Status and/or Components of the Vascular Endothelial Growth Factor (VEGF)/Epidermal Growth Factor Receptor (EGFR) Pathway
Hide Description Components of the VEGF and EGFR pathways were to be evaluated using Western blot analysis at baseline and specified timepoints following initiation of therapy when tumor tissue was available.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not enough samples for meaningful analysis.
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density
Hide Description Tumor tissue sections were to be stained with hematoxylin and eosin (H and E) and endothelial cell markers at baseline and specified timepoints following initiation of therapy (when tumor tissue was available)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not enough samples for meaningful analysis.
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib)
Hide Description If an adequate number of responses were seen, the relation of these responses to the presence/absence of inactivating VHL mutations in tumor tissue would have been assessed.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not enough samples for meaningful analysis.
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description:
Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 11.5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clear Cell Renal Carcinoma Patients
Hide Arm/Group Description Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
All-Cause Mortality
Clear Cell Renal Carcinoma Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clear Cell Renal Carcinoma Patients
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Gastrointestinal disorders   
Diarrhea  1  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clear Cell Renal Carcinoma Patients
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  1/3 (33.33%)  1
Gastrointestinal disorders   
Dry mouth/salivary gland (xerostomia)  1  1/3 (33.33%)  1
Nausea  1  1/3 (33.33%)  2
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/3 (33.33%)  1
Alkaline phosphatase  1  1/3 (33.33%)  1
Bicarbonate, serum-low  1  1/3 (33.33%)  1
Creatinine  1  1/3 (33.33%)  1
Prolonged QTc interval  1  1/3 (33.33%)  1
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  1/3 (33.33%)  1
Glucose, serum-high (hyperglycemia)  1  1/3 (33.33%)  1
Magnesium, serum-high (hypermagnesemia)  1  1/3 (33.33%)  1
Magnesium, serum-low (hypomagnesemia)  1  1/3 (33.33%)  1
Phosphate, serum-low (hypophosphatemia)  1  1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders   
Pain::Neck  1 [1]  1/3 (33.33%)  1
Nervous system disorders   
Neurology - Other (Specify, lightheadedness)  1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
Rash: acne/acneiform  1  1/3 (33.33%)  1
Vascular disorders   
Hypertension  1  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Neck and shoulder
Study was designed to accrue up to 37 patients but only 3 were enrolled. Study was terminated due to low accrual.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marston Linehan, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-6353
Responsible Party: W. Marston Linehan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01372813     History of Changes
Obsolete Identifiers: NCT00608114
Other Study ID Numbers: 080039
08-C-0039
First Submitted: June 11, 2011
First Posted: June 14, 2011
Results First Submitted: December 19, 2011
Results First Posted: March 12, 2012
Last Update Posted: October 23, 2015