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Trial record 30 of 39 for:    Von Hippel-Lindau Disease (VHL)

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Trial only accrued 3 participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clear Cell Renal Carcinoma Patients 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.

Participant Flow:   Overall Study
    Clear Cell Renal Carcinoma Patients
STARTED   3 
COMPLETED   3 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clear Cell Renal Carcinoma Patients 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.

Baseline Measures
   Clear Cell Renal Carcinoma Patients 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.8  (5.43) 
Gender 
[Units: Participants]
 
Female   1 
Male   2 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   3 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   3 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   3 


  Outcome Measures

1.  Primary:   Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR))   [ Time Frame: 12 months ]

2.  Secondary:   Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2)   [ Time Frame: 12 months ]

3.  Secondary:   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   [ Time Frame: 12 months ]

4.  Secondary:   Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria   [ Time Frame: 12 months ]

5.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 11.5 months ]

6.  Secondary:   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   [ Time Frame: 12 months ]

7.  Secondary:   Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)   [ Time Frame: 12 months ]

8.  Secondary:   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   [ Time Frame: 12 months ]

9.  Secondary:   The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density   [ Time Frame: 12 months ]

10.  Secondary:   Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was designed to accrue up to 37 patients but only 3 were enrolled. Study was terminated due to low accrual.


  More Information

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
e-mail: linehanm@mail.nih.gov


Publications:

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