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Clobetasol for Oral Graft-Versus-Host Disease

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ClinicalTrials.gov Identifier: NCT01557517
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Pavletic, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Oral Chronic Graft vs Host Disease
Interventions Drug: Clobetasol Oral Rinse
Drug: Placebo oral rinse
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clobetasol Followed by Assessment + 2 Weeks Clobetasol Placebo Followed by Clobetasol
Hide Arm/Group Description

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Period Title: Overall Study
Started 19 21
Completed 17 17
Not Completed 2 4
Reason Not Completed
Death             1             0
Refused further treatment             0             2
Adverse Event             0             2
Pt declined before treatment started             1             0
Arm/Group Title Clobetasol Placebo Total
Hide Arm/Group Description

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Total of all reporting groups
Overall Number of Baseline Participants 19 21 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  94.7%
17
  81.0%
35
  87.5%
>=65 years
1
   5.3%
4
  19.0%
5
  12.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 21 participants 40 participants
44.09  (14.52) 41.4  (16.53) 42.75  (15.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Female
6
  31.6%
11
  52.4%
17
  42.5%
Male
13
  68.4%
10
  47.6%
23
  57.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Black or African American
3
  15.8%
3
  14.3%
6
  15.0%
White
15
  78.9%
13
  61.9%
28
  70.0%
Asian
0
   0.0%
3
  14.3%
3
   7.5%
Unknown
1
   5.3%
0
   0.0%
1
   2.5%
Multiple Race
0
   0.0%
2
   9.5%
2
   5.0%
Mexican, Puerto Rican, Cuban, Central or So. Amer.
3
  15.8%
3
  14.3%
6
  15.0%
Not meeting definition for Hispanic or Latino
16
  84.2%
18
  85.7%
34
  85.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 21 participants 40 participants
19
 100.0%
21
 100.0%
40
 100.0%
1.Primary Outcome
Title Percentage of Participants With a Response as Assessed by the 273-point Oral Mucositis Rating Scale (OMRS) Who Received Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-versus-host-disease (cGVHD) During a Four-week Treatment Period
Hide Description Mucosal changes were assessed by the Oral Mucositis Rating Scale. The primary endpoint was evaluated using the OMRS. Oral tissue changes are rated on a scale of 0-3 compared with normal oral tissue (0-normal/no change, 1-mild change, 2-moderate change, and 3-severe change). Total score is the sum of all OMRS items with a possible range of 0. Total score is the sum of all OMRS items with a possible range of 0-273. Lower score=more normal oral mucosa. There is no standard definition of response in this field. Definitions we used in this pilot study to grade the response to study intervention are: Progress of 25% of initial score (rounded to the closest number) on the OMRS scale. Completion (PD) is defined as an increase of 25% of initial score (rounded to the closest number). Partial Response (PR) is defined as a decrease Response (CR) is defined as a PR plus a score of 0 on the erythema and ulceration components. Stable Disease (SD) does not meet criteria for progression or response.
Time Frame At 4 weeks on active treatment
Hide Outcome Measure Data
Hide Analysis Population Description
18/19 are analyzed in the Clobetasol arm/group because one participant declined participation before treatment started.
Arm/Group Title Clobetasol (2-week) Placebo (2-week) Combined Group 4-week Data
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day. This group includes patients initially randomized to the clobetasol group as well as the patients initially randomized to placebo, who crossed over to the clobetasol 0.05% oral rinse group after 2 weeks of placebo use and the interim assessment and then completed 4 weeks of clobetasol rinse use.
Overall Number of Participants Analyzed 18 21 31
Measure Type: Number
Unit of Measure: percentage of participants
Progressive Disease 0 0 0
Partial Response 72 9 72
Complete Response 0 0 19
Stable Disease 28 91 9
2.Secondary Outcome
Title Percent Change in Participants' Raw Score of Oral cGVHD Related Pain on a 0-10 Rating Scale
Hide Description Oral cavity pain was assessed by an oral cavity specific quality of life questionnaire. Pain was rated based on a 0-10 rating scale on which subjects selected a single integer. 0 = no pain and 10 = worst pain. A negative value indicates an increase in oral pain. A positive value indicates an improvement in patient-perceived oral pain.
Time Frame Baseline to Day 14 and baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
18/19 are analyzed in the Clobetasol grp because one participant declined participation before treatment started. Clobetasol and Placebo grps were not assessed separately at Day 28. Only those pts who completed 4 wks of active clobetasol treatment and did not have an active oral infection at the 4 week timepoint were included in the final analysis.
Arm/Group Title Clobetasol Placebo Combined Group 4-week Data
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day. This group includes patients initially randomized to the clobetasol group as well as the patients initially randomized to placebo, who crossed over to the clobetasol 0.05% oral rinse group after 2 weeks of placebo use and the interim assessment and then completed 4 weeks of clobetasol rinse use.
Overall Number of Participants Analyzed 18 21 31
Mean (Standard Deviation)
Unit of Measure: Percent change
Day 14 13  (116) 21  (67) 31  (86)
Day 28 NA [1]   (NA) NA [2]   (NA) 45  (146)
[1]
Day 28 data for this Clobetasol Arm/Group is collapsed within the Combined Group 4-week data Arm/Group.
[2]
Day 28 data for this Placebo Arm/Group is collapsed within the Combined Group 4-week data Arm/Group.
3.Secondary Outcome
Title Percent Change in Participants' Raw Score of Oral cGVHD Related Sensitivity on a 0-10 Rating Scale
Hide Description Oral cavity sensitivity was assessed by an oral cavity specific quality of life questionnaire. Sensitivity was rated based on a 0-10 rating scale on which subjects selected a single integer. 0 = no sensitivity and 10 = worst sensitivity. A negative value indicates an increase in oral sensitivity. A positive value indicates an improvement in patient-perceived oral sensitivity.
Time Frame Baseline and 4 weeks on active treatment
Hide Outcome Measure Data
Hide Analysis Population Description
18/19 are analyzed in the Clobetasol grp because one participant declined participation before treatment started.
Arm/Group Title Clobetasol Placebo Combined Group 4-week Data
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day. This group includes patients initially randomized to the clobetasol group as well as the patients initially randomized to placebo, who crossed over to the clobetasol 0.05% oral rinse group after 2 weeks of placebo use and the interim assessment and then completed 4 weeks of clobetasol rinse use.
Overall Number of Participants Analyzed 18 21 31
Mean (Standard Deviation)
Unit of Measure: Percent change
39  (168) 19  (62) 41  (106)
4.Secondary Outcome
Title Percent Change in Participants' Raw Score of Oral cGVHD Related Dryness on a 0-10 Rating Scale
Hide Description Oral cavity dryness was assessed by an oral cavity specific quality of life questionnaire. Dryness was rated based on a 0-10 rating scale on which subjects selected a single integer. 0 = no dryness and 10 = worst dryness. A negative value indicates an increase in patient-perceived oral dryness. A positive value indicates an improvement in patient-perceived oral dryness.
Time Frame Baseline and 4 weeks on active treatment
Hide Outcome Measure Data
Hide Analysis Population Description
18/19 are analyzed in the Clobetasol grp because one participant declined participation before treatment started.
Arm/Group Title Clobetasol Placebo Combined Group 4-week Data
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day. This group includes patients initially randomized to the clobetasol group as well as the patients initially randomized to placebo, who crossed over to the clobetasol 0.05% oral rinse group after 2 weeks of placebo use and the interim assessment and then completed 4 weeks of clobetasol rinse use.
Overall Number of Participants Analyzed 18 21 31
Mean (Standard Deviation)
Unit of Measure: Percent change
8  (115) 15  (229) 30  (111)
5.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Clobetasol During Pharmacokinetic Testing
Hide Description Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule.
Time Frame pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, pharmacokinetic testing was only done on the first 10 patients in the clobetasol group. We are reporting a calculation based on these 3 time points, not a number that can be reported at 3 discrete times.
Arm/Group Title Clobetasol
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.818  (0.649)
6.Secondary Outcome
Title Plasma Concentrations of Clobetasol Mouth Rinse in cGVHD Patients at Baseline (Day 0) and Day 28
Hide Description Peripheral blood was drawn at baseline and day 28 of clobetasol rinse use, and clobetasol levels were measured in the blood sample. Plasma concentrations of clobetasol were measured using a validated LC-MS/MS assay with a lower limit of quantification of 0.05 ng/mL. Any values below detectable limit or with no peak were adjusted to 0.
Time Frame Baseline Day 0 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
37/40 participants are included in this laboratory assessment as interpretable data was not available for 3 patient samples.
Arm/Group Title Combined Group 4-week Data
Hide Arm/Group Description:
Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day. This group includes patients initially randomized to the clobetasol group as well as the patients initially randomized to placebo, who crossed over to the clobetasol 0.05% oral rinse group after 2 weeks of placebo use and the interim assessment and then completed 4 weeks of clobetasol rinse use.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Day 0) 0.0146  (0.0578)
Day 28 0.329  (0.343)
7.Secondary Outcome
Title Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 62 months and 12 days.
Hide Outcome Measure Data
Hide Analysis Population Description
18/19 are analyzed in the Clobetasol arm/group because one participant declined participation before treatment started.
Arm/Group Title Clobetasol Placebo First (During Clobetasol Phase Only) Placebo (During 2-week Placebo Phase Only)
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Overall Number of Participants Analyzed 18 21 21
Measure Type: Count of Participants
Unit of Measure: Participants
17
  94.4%
21
 100.0%
6
  28.6%
8.Secondary Outcome
Title Time to Maximum Plasma Concentration (Cmax) of Clobetasol
Hide Description Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule.
Time Frame pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, pharmacokinetic testing was only done on the first 10 patients in the clobetasol group. We are reporting a calculation based on these 3 time points, not a number that can be reported at 3 discrete times.
Arm/Group Title Clobetasol
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: hours
1.27  (0.59)
9.Secondary Outcome
Title Area Under the Plasma Concentration vs Time Curve for All Time Points
Hide Description Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule.
Time Frame pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, pharmacokinetics testing was only done on the first 10 patients in the clobetasol group.
Arm/Group Title Clobetasol
Hide Arm/Group Description:

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Hr*ng/mL
0.974  (0.729)
Time Frame Date treatment consent signed to date off study, approximately 62 months and 12 days.
Adverse Event Reporting Description 18/19 are participants in the Clobetasol arm/group because one participant declined participation before treatment started.
 
Arm/Group Title Clobetasol Placebo First (During Clobetasol Phase Only) Placebo (During 2-week Placebo Phase Only)
Hide Arm/Group Description

Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.

Clobetasol Oral Rinse: Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Placebo oral rinse: Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

All-Cause Mortality
Clobetasol Placebo First (During Clobetasol Phase Only) Placebo (During 2-week Placebo Phase Only)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)      0/21 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clobetasol Placebo First (During Clobetasol Phase Only) Placebo (During 2-week Placebo Phase Only)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/18 (16.67%)      4/21 (19.05%)      0/21 (0.00%)    
Blood and lymphatic system disorders       
Anemia  1  1/18 (5.56%)  4 0/21 (0.00%)  0 0/21 (0.00%)  0
Cardiac disorders       
Atrial fibrillation  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Sinus tachycardia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Supraventricular tachycardia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Endocrine disorders       
Adrenal insufficiency  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders       
Diarrhea  1  2/18 (11.11%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Duodenal hemorrhage  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Duodenal perforation  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Duodenal ulcer  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Ileus  1  1/18 (5.56%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations       
Enterocolitis infectious  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Lung infection  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Upper respiratory infection  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Spinal fracture  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Investigations       
Aspartate aminotransferase increased  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Blood bilirubin increased  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Cardiac troponin I increased  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Lymphocyte count decreased  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Platelet count decreased  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders       
Hyperglycemia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Hyperkalemia  1  1/18 (5.56%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Hypoalbuminemia  1  1/18 (5.56%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Hypocalcemia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Hypokalemia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Hyponatremia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Hypophosphatemia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders       
Syncope  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  1/18 (5.56%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Urinary retention  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Dyspnea  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1 [1]  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Hypoxia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders       
Hypertension  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Hypotension  1  1/18 (5.56%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
enlarging mediastinal lymphadenopathy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clobetasol Placebo First (During Clobetasol Phase Only) Placebo (During 2-week Placebo Phase Only)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/18 (88.89%)      21/21 (100.00%)      6/21 (28.57%)    
Blood and lymphatic system disorders       
Anemia  1  0/18 (0.00%)  0 3/21 (14.29%)  3 0/21 (0.00%)  0
Cardiac disorders       
Sinus tachycardia  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  0/18 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Endocrine disorders       
Adrenal insufficiency  1  10/18 (55.56%)  10 11/21 (52.38%)  11 0/21 (0.00%)  0
Cushingoid  1  3/18 (16.67%)  3 1/21 (4.76%)  1 0/21 (0.00%)  0
Eye disorders       
Dry eye  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Diarrhea  1  3/18 (16.67%)  3 1/21 (4.76%)  1 0/21 (0.00%)  0
Cataract  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Conjunctivitis  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Corneal ulcer  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Gastrointestinal disorders       
Mucositis oral  1  3/18 (16.67%)  3 2/21 (9.52%)  2 0/21 (0.00%)  0
Nausea  1  1/18 (5.56%)  1 3/21 (14.29%)  3 1/21 (4.76%)  1
Abdominal distension  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Bloating  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Dyspepsia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Oral dysesthesia  1  3/18 (16.67%)  3 2/21 (9.52%)  2 0/21 (0.00%)  0
Oral hemorrhage  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Oral pain  1  1/18 (5.56%)  1 2/21 (9.52%)  2 0/21 (0.00%)  0
Vomiting  1  2/18 (11.11%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Anal hemorrhage  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Constipation  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Dental caries  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Dysphagia  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Hemorrhoidal hemorrhage  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
General disorders       
Fatigue  1  0/18 (0.00%)  0 3/21 (14.29%)  3 1/21 (4.76%)  1
Edema limbs  1  1/18 (5.56%)  1 1/21 (4.76%)  1 1/21 (4.76%)  1
Edema trunk  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Edema face  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Flu like symptoms  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Infections and infestations       
Upper respiratory infection  1  2/18 (11.11%)  2 3/21 (14.29%)  3 0/21 (0.00%)  0
Infections and infestations - Other, specify  1 [1]  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Mucosal infection  1  5/18 (27.78%)  8 6/21 (28.57%)  6 0/21 (0.00%)  0
Skin infection  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Cervicitis infection  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Infections and infestations - Other, specify  1 [2]  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Urinary tract infection  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Vaginal infection  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications       
Spinal fracture  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Investigations       
Lymphocyte count decreased  1  6/18 (33.33%)  12 8/21 (38.10%)  8 0/21 (0.00%)  0
Platelet count decreased  1  2/18 (11.11%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Alanine aminotransferase increased  1  1/18 (5.56%)  1 4/21 (19.05%)  4 0/21 (0.00%)  0
Creatinine increased  1  2/18 (11.11%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Neutrophil count decreased  1  2/18 (11.11%)  4 3/21 (14.29%)  3 0/21 (0.00%)  0
White blood cell decreased  1  1/18 (5.56%)  1 4/21 (19.05%)  4 0/21 (0.00%)  0
Activated partial thromboplastin time prolonged  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Alkaline phosphatase increased  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Aspartate aminotransferase increased  1  0/18 (0.00%)  0 3/21 (14.29%)  3 0/21 (0.00%)  0
Hemoglobin increased  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Lymphocyte count increased  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Metabolism and nutrition disorders       
Hypoalbuminemia  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Hypophosphatemia  1  1/18 (5.56%)  1 7/21 (33.33%)  9 0/21 (0.00%)  0
Anorexia  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Hyperkalemia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Hypernatremia  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Glucose intolerance  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Hypercalcemia  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Hyponatremia  1  0/18 (0.00%)  0 2/21 (9.52%)  2 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Generalized muscle weakness  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Muscle weakness lower limb  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Back pain  1  0/18 (0.00%)  0 2/21 (9.52%)  2 0/21 (0.00%)  0
Myalgia  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Non-cardiac chest pain  1  0/18 (0.00%)  0 1/21 (4.76%)  1 1/21 (4.76%)  1
Nervous system disorders       
Dysgeusia  1  3/18 (16.67%)  3 8/21 (38.10%)  8 0/21 (0.00%)  0
Headache  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Paresthesia  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Presyncope  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Tremor  1  1/18 (5.56%)  1 2/21 (9.52%)  2 0/21 (0.00%)  0
Dizziness  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Psychiatric disorders       
Insomnia  1  5/18 (27.78%)  5 7/21 (33.33%)  7 1/21 (4.76%)  1
Anxiety  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Depression  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Renal and urinary disorders       
Urinary frequency  1  1/18 (5.56%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Reproductive system and breast disorders       
Genital edema  1  1/18 (5.56%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/18 (5.56%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Dyspnea  1  2/18 (11.11%)  2 1/21 (4.76%)  1 0/21 (0.00%)  0
Laryngeal inflammation  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Productive cough  1  0/18 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Sore throat  1  0/18 (0.00%)  0 1/21 (4.76%)  1 1/21 (4.76%)  1
Wheezing  1  0/18 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash maculo-papular  1  2/18 (11.11%)  2 0/21 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders       
Hypertension  1  4/18 (22.22%)  6 2/21 (9.52%)  2 0/21 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
EBV low positive
[2]
CMV reactivation
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
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Pavletic
Organization: National Cancer Institute
Phone: 301-402-4899
EMail: steven_pavletic@nih.gov
Layout table for additonal information
Responsible Party: Steven Pavletic, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01557517     History of Changes
Other Study ID Numbers: 120068
12-C-0068
First Submitted: March 16, 2012
First Posted: March 19, 2012
Results First Submitted: August 10, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019