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Trial record 23 of 41 for:    Von Hippel-Lindau Disease (VHL)

Phase II Study of Vandetanib in Individuals With Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00566995
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : March 11, 2015
Last Update Posted : October 30, 2018
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
Conditions Renal Cancer
Von Hippel Lindau
Intervention Drug: ZACTIMA (Vandetanib) (ZD6474)
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description 300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Period Title: Overall Study
Started 37
Completed 30
Not Completed 7
Reason Not Completed
Toxicity             4
Withdrew consent             3
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description 300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  97.3%
>=65 years
1
   2.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
46.65  (9.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
21
  56.8%
Male
16
  43.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Hispanic or Latino
2
   5.4%
Not Hispanic or Latino
34
  91.9%
Unknown or Not Reported
1
   2.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.7%
White
34
  91.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
 100.0%
1.Primary Outcome
Title Overall Response Rate.
Hide Description Overall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline and every 3 cycles, up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
Partial Response 3
Complete Response 0
Stable Disease 75
Progressive Disease 0
Not Evaluable 22
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 72 months and 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
37
 100.0%
3.Secondary Outcome
Title Time To Progression (TTP)
Hide Description Time to progression is defined as the time from the start of treatment to progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, with death being treated as a censored event. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new lesions, developing a surgical size tumor that should be resected. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline and every 3 cycles while on study, up to 2 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: Months
13.8
(11.0 to 22.1)
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival is defined as time from initiation of treatment to either progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline and every 3 cycles while on study, up to 2 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: Months
13.8
(11.0 to 22.1)
5.Secondary Outcome
Title Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells
Hide Description Peripheral blood was collected and analyzed by multiparametric flow cytometry for analysis of angiogenesis markers.
Time Frame Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No samples were received for 2/37 patients.
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 35
Median (Full Range)
Unit of Measure: Cells per 10^6 mononuclear cells
Cycle 1 Day 1 Pre treatment Number Analyzed 35 participants
214.44
(0 to 906.7)
Cycle 1 Day 1, 4 hours post Number Analyzed 33 participants
115.79
(0 to 282.69)
Cycle 2 Day 1 Number Analyzed 30 participants
160.20
(0 to 640.6)
6.Secondary Outcome
Title Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC)
Hide Description Peripheral blood was collected and analyzed by multiparametric flow cytometry.
Time Frame Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No samples were received for 2/37 participants.
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 35
Median (Full Range)
Unit of Measure: CEC per 10^6 mononuclear cells
Cycle 1 day 1 Pre treatment Number Analyzed 35 participants
83.83
(0 to 314.20)
Cycle 1 Day 1, 4 hours post Number Analyzed 33 participants
63.08
(0 to 307.40)
Cycle 2 Day 1 Number Analyzed 30 participants
155.8
(0 to 2480)
7.Secondary Outcome
Title Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL)
Hide Description Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline and every 3 cycles while on study, up to 2 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only two participants had target lesions that could be measured.
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
0
   0.0%
Progressive Disease
0
   0.0%
Stable Disease
2
 100.0%
8.Secondary Outcome
Title Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL)
Hide Description Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline and every 3 cycles while on study, up to 2 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only two participants had target lesions that could be measured.
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
0
   0.0%
Progressive Disease
0
   0.0%
Stable Disease
2
 100.0%
9.Secondary Outcome
Title Response in Pheochromocytomas Associated With Von Hippel Lindau (VHL)
Hide Description Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline and every 3 cycles while on study, up to 2 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because no participants had measurable lesions.
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title Change in Plasma Biomarkers Vascular Endothelial Growth Factor (VEGF) and Soluble Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Before and After Treatment With Vandetanib
Hide Description 5-10cc venous blood was collected for evaluation of basal plasma levels of angiogenesis biomarkers VEGF and VEGFR-2.
Time Frame Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was intended to be exploratory. Several other studies established that therapy with VEGFR agents modulated serum/plasma VEGF and soluble VEGFR2 levels, but there was no consistent & established correlation with clinical outcome. These analyses were unlikely to add further to our ability to evaluate the major objectives of the study.
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description:
300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 72 months and 14 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib in Participants With Kidney Cancer
Hide Arm/Group Description 300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
All-Cause Mortality
Vandetanib in Participants With Kidney Cancer
Affected / at Risk (%)
Total   0/37 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib in Participants With Kidney Cancer
Affected / at Risk (%) # Events
Total   5/37 (13.51%)    
Eye disorders   
Retinal detachment  1  1/37 (2.70%)  2
General disorders   
Constitutional Symptoms - Other (Specify, generalized weakness)  1  1/37 (2.70%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/37 (2.70%)  1
Pain - Other (Specify, jaw pain and L shoulder pain)  1  1/37 (2.70%)  1
Rigors/chills  1  1/37 (2.70%)  1
Metabolism and nutrition disorders   
Calcium, serum-high (hypercalcemia)  1  1/37 (2.70%)  3
Nervous system disorders   
Syncope (fainting)  1  1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/37 (2.70%)  1
Pain::Chest wall  1  1/37 (2.70%)  1
Pulmonary/Upper Respiratory - Other, bronchitis; viral pneumonia  1  1/37 (2.70%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vandetanib in Participants With Kidney Cancer
Affected / at Risk (%) # Events
Total   37/37 (100.00%)    
Blood and lymphatic system disorders   
Edema: limb  1  2/37 (5.41%)  3
Hemoglobin  1  5/37 (13.51%)  10
Leukocytes (total WBC)  1  3/37 (8.11%)  4
Lymphopenia  1  17/37 (45.95%)  28
Neutrophils/granulocytes (ANC/AGC)  1  2/37 (5.41%)  3
Platelets  1  4/37 (10.81%)  9
Cardiac disorders   
Cardiac Arrhythmia - Other (Specify, __)  1 [1]  1/37 (2.70%)  2
Hypertension  1  9/37 (24.32%)  13
Hypotension  1  1/37 (2.70%)  1
Palpitations  1  2/37 (5.41%)  2
Prolonged QTc interval  1  24/37 (64.86%)  119
Supraventricular and nodal arrhythmia::Sinus bradycardia  1  1/37 (2.70%)  2
Cardiac arrhythmia-Other, Specify (tachycardia)  1  1/37 (2.70%)  1
Ear and labyrinth disorders   
Otitis, external ear (non-infectious)  1  1/37 (2.70%)  1
Endocrine disorders   
Hot flashes/flushes  1  1/37 (2.70%)  1
Thyroid function, low (hypothyroidism)  1  1/37 (2.70%)  1
Eye disorders   
Dry eye syndrome  1  5/37 (13.51%)  6
Ocular surface disease  1  1/37 (2.70%)  1
Ocular/Visual - Other (Specify, corneal epithelial defect)  1 [2]  1/37 (2.70%)  1
Vision-blurred vision  1  2/37 (5.41%)  2
Vision-flashing lights/floaters  1  2/37 (5.41%)  2
Ocular/Visual - Other (Specify, corneal verticillata)  1  1/37 (2.70%)  1
Ocular/Visual - Other (Specify, halos at night)  1  1/37 (2.70%)  1
Ocular/Visual - Other (Specify, ocular/visual other-vortex keratopathy)  1  1/37 (2.70%)  1
Gastrointestinal disorders   
Anorexia  1  2/37 (5.41%)  2
Constipation  1  3/37 (8.11%)  3
Diarrhea  1  24/37 (64.86%)  36
Dry mouth/salivary gland (xerostomia)  1  3/37 (8.11%)  3
Dysphagia (difficulty swallowing)  1  1/37 (2.70%)  1
Flatulence  1  3/37 (8.11%)  3
Heartburn/dyspepsia  1  3/37 (8.11%)  4
Hemorrhoids  1  1/37 (2.70%)  1
Malabsorption  1  1/37 (2.70%)  1
Mucositis/stomatitis (clinical exam)::Oral cavity  1  1/37 (2.70%)  1
Nausea  1  16/37 (43.24%)  24
Pain::Abdomen NOS  1  2/37 (5.41%)  4
Pain::Dental/teeth/peridontal  1  1/37 (2.70%)  1
Taste alteration (dysgeusia)  1  1/37 (2.70%)  1
Vomiting  1  6/37 (16.22%)  8
General disorders   
Constitutional Symptoms - Other (Specify, extreme hunger and jitterness)  1  1/37 (2.70%)  1
Fatigue (asthenia, lethargy, malaise)  1  16/37 (43.24%)  21
Insomnia  1  11/37 (29.73%)  16
Pain - Other (Specify, bilateral ankle pain)  1 [3]  1/37 (2.70%)  1
Sweating (diaphoresis)  1  3/37 (8.11%)  3
Weight gain  1  2/37 (5.41%)  3
Weight loss  1  9/37 (24.32%)  14
Pain - Other (Specify, cramp in extremities)  1  1/37 (2.70%)  1
Pain - Other (Specify, dysuria)  1  1/37 (2.70%)  1
Pain - Other (Specify, intermittent chest/thorax)  1  1/37 (2.70%)  1
Pain - Other (Specify, left elbow)  1  1/37 (2.70%)  1
Pain - Other (Specify, myalgia)  1  1/37 (2.70%)  1
Pain - Other (Specify, pain bilateral feet)  1  1/37 (2.70%)  1
Pain - Other (Specify, pain under R ribcage)  1  1/37 (2.70%)  1
Pain - Other (Specify, pain-L elbow pain)  1  1/37 (2.70%)  1
Pain - Other (Specify, pain-R ankle pain)  1  1/37 (2.70%)  1
Pain - Other (Specify, R shoulder)  1  1/37 (2.70%)  1
Pain - Other (Specify, suprapubic)  1  1/37 (2.70%)  1
Pain - Other (Specify, tooth sensitivity)  1  1/37 (2.70%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/37 (2.70%)  1
Immune system disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  3/37 (8.11%)  3
Infections and infestations   
Infection - Other (Specify, bladder infection)  1  1/37 (2.70%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Dental-tooth  1  1/37 (2.70%)  1
Infection - Other (Specify, bladder (urinary)  1  1/37 (2.70%)  1
Infection - Other (Specify, sinusitis)  1  1/37 (2.70%)  1
Infection - Other (Specify, tooth abscess)  1  1/37 (2.70%)  1
Infection - Other (Specify, sinus infection)  1  1/37 (2.70%)  1
Metabolism and nutrition disorders   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  24/37 (64.86%)  75
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  17/37 (45.95%)  37
Albumin, serum-low (hypoalbuminemia)  1  17/37 (45.95%)  33
Alkaline phosphatase  1  13/37 (35.14%)  26
Bicarbonate, serum-low  1  6/37 (16.22%)  6
Bilirubin (hyperbilirubinemia)  1  5/37 (13.51%)  8
CPK (creatine phosphokinase)  1  15/37 (40.54%)  31
Calcium, serum-high (hypercalcemia)  1  6/37 (16.22%)  9
Calcium, serum-low (hypocalcemia)  1  7/37 (18.92%)  14
Creatinine  1  26/37 (70.27%)  70
Glucose, serum-high (hyperglycemia)  1  20/37 (54.05%)  56
Glucose, serum-low (hypoglycemia)  1  14/37 (37.84%)  29
Hemoglobinuria  1  11/37 (29.73%)  18
Magnesium, serum-high (hypermagnesemia)  1  9/37 (24.32%)  10
Magnesium, serum-low (hypomagnesemia)  1  16/37 (43.24%)  37
Phosphate, serum-low (hypophosphatemia)  1  15/37 (40.54%)  29
Potassium, serum-high (hyperkalemia)  1  11/37 (29.73%)  19
Potassium, serum-low (hypokalemia)  1  6/37 (16.22%)  7
Proteinuria  1  21/37 (56.76%)  44
Sodium, serum-high (hypernatremia)  1  2/37 (5.41%)  2
Sodium, serum-low (hyponatremia)  1  14/37 (37.84%)  25
Triglyceride, serum-high (hypertriglyceridemia)  1  2/37 (5.41%)  2
Uric acid, serum-high (hyperuricemia)  1  13/37 (35.14%)  32
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other (Specify, crushed thumb)  1  1/37 (2.70%)  1
Pain::Back  1  2/37 (5.41%)  3
Pain::Joint  1  1/37 (2.70%)  1
Pain::Muscle  1  1/37 (2.70%)  3
Seroma  1  1/37 (2.70%)  2
Nervous system disorders   
Dizziness  1  5/37 (13.51%)  7
Mood alteration::Agitation  1  1/37 (2.70%)  1
Mood alteration::Anxiety  1  9/37 (24.32%)  12
Mood alteration::Depression  1  6/37 (16.22%)  6
Neurology - Other (Specify, R lower extremity foot weakness)  1  1/37 (2.70%)  1
Neuropathy: sensory  1  2/37 (5.41%)  2
Pain::Head/headache  1  3/37 (8.11%)  4
Tremor  1  2/37 (5.41%)  2
Renal and urinary disorders   
Cystitis  1  2/37 (5.41%)  2
Hemorrhage, GU::Bladder  1  6/37 (16.22%)  8
Hemorrhage, GU::Urinary NOS  1  5/37 (13.51%)  5
Hemorrhage/Bleeding - Other (Specify, hematuria)  1  1/37 (2.70%)  1
Incontinence, urinary  1  1/37 (2.70%)  1
Renal/Genitourinary - Other (Specify, hematuria)  1  1/37 (2.70%)  1
Urinary frequency/urgency  1  2/37 (5.41%)  4
Renal/Genitourinary - Other (Specify, LUTS Syndrome - decreased urinary flow)  1  1/37 (2.70%)  1
Renal/Genitourinary - Other (Specify, microscopic hematuria)  1  1/37 (2.70%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  2/37 (5.41%)  2
Hemorrhage, GU::Vagina  1  1/37 (2.70%)  1
Pain::Pelvis  1  2/37 (5.41%)  2
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/37 (2.70%)  1
Cough  1  6/37 (16.22%)  7
Hemorrhage, pulmonary/upper respiratory::Nose  1  1/37 (2.70%)  1
Pulmonary/Upper Respiratory - Other (Specify, asthma)  1  1/37 (2.70%)  1
Pulmonary/Upper Respiratory - Other (Specify, bronchitis)  1  1/37 (2.70%)  1
Pulmonary/Upper Respiratory - Other (Specify, cold)  1  1/37 (2.70%)  1
Pulmonary/Upper Respiratory - Other (Specify, cold symptoms)  1  1/37 (2.70%)  1
Pulmonary/Upper Respiratory - Other (Specify, congestion)  1  1/37 (2.70%)  1
Pulmonary/Upper Respiratory - Other (Specify, upper respiratory infection)  1  1/37 (2.70%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify, __)  1 [4]  1/37 (2.70%)  1
Dry skin  1  5/37 (13.51%)  5
Hair loss/alopecia (scalp or body)  1  1/37 (2.70%)  1
Hyperpigmentation  1  2/37 (5.41%)  2
Pain::Oral-gums  1  1/37 (2.70%)  1
Photosensitivity  1  2/37 (5.41%)  2
Pruritus/itching  1  1/37 (2.70%)  3
Rash/desquamation  1  4/37 (10.81%)  7
Rash: acne/acneiform  1  30/37 (81.08%)  48
Dermatology/Skin - Other (Specify, dry scalp)  1  1/37 (2.70%)  1
Dermatology/Skin - Other (Specify,dry, chapped lips)  1  1/37 (2.70%)  1
Dermatology/Skin - Other (Specify,eczematous dermatitis  1  1/37 (2.70%)  1
Dermatology/Skin - Other (Specify, erythema L leg)  1  1/37 (2.70%)  1
Dermatology/Skin - Other (Specify, erythema on face)  1  1/37 (2.70%)  1
Dermatology/Skin - Other (Specify, paronychia of L great toe)  1  1/37 (2.70%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
nonspecific T-wave abnormality
[2]
corneal epithelial defect
[3]
bilateral ankle pain
[4]
cold sore on lip-herpes simplex
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: Dr. W. Marston Linehan
Organization: National Cancer Institute
Phone: 301-496-6353
Publications:
Vitael, S, Cunningham, D. Meleth, A., Bishop R., Clayton, Datile, M, Linehan WM, Srinivasan R, Meyerle, C. Development of a New Grading System for Corneal Verticillata. ARVO meeting May 8, 2013
Vitael, S, Cunningham, D. Meleth, A., Bishop R., Clayton, Datile, M, Linehan WM, Srinivasan R, Meyerle, C. Development of a New Grading System for Corneal Verticillata. ARVO meeting May 2012.
Responsible Party: W. Marston Linehan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00566995     History of Changes
Other Study ID Numbers: 080020
08-C-0020
First Submitted: December 1, 2007
First Posted: December 4, 2007
Results First Submitted: February 12, 2015
Results First Posted: March 11, 2015
Last Update Posted: October 30, 2018