Impact of Vorinostat on Pruritus Signaling Pathways - Merck Study
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|ClinicalTrials.gov Identifier: NCT01801670|
Recruitment Status : Withdrawn (Enrollment was too slow, so no participants were ever enrolled.)
First Posted : March 1, 2013
Last Update Posted : January 27, 2015
|Condition or disease||Intervention/treatment|
|Pruritus||Procedure: Biopsy Procedure: Blood|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Phase IV Study Of The Impact Of Vorinostat On Cellular Signaling And Cytokine Production In Cutaneous T-Cell Lymphoma Patients With Pruritus|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
MF patients for blood & biopsy
Participants who are cared for at Boston Medical Center will first be assessed by physicians of the CTCL multi-specialty clinic if vorinostat, administered per standard of care, is an appropriate therapy for their CTCL. The decision to invite patients to participate in this study is (1) separate from the above described clinical decision to utilize vorinostat, and (2) will be offered subsequent to the clinical decision to utilize vorinostat. Vorinostat (Zolinza) will be administered as follows: each subject will receive each month for the first 3 months (cycle 1 to 3) 3 capsules of vorinostat 100 mg po daily. For months 4-6 (cycles 4 to 6), subjects will receive each month for 4 capsules of vorinostat 100 mg po daily.
Two 6 mm skin punch biopsies (one from pruritic skin and from involved non pruritic skin).
Peripheral blood (10 mls) to be drawn and used for cytokine analysis.
- the percentage change in pSTAT3 expression among patients reporting a relief in their pruritus, irrespective of lesion clearing [ Time Frame: 6 months ]
For each time point and each skin type, pSTAT3 staining will be measured as strong (2+), weak (1+), none (0). At each time point, patients will report pruritus on a visual analogue score (VAS) from 0-100 mm (0, none; 100, worst imaginable). Meaningful change in pruritus is a change in VAS score of 30 mm or more from baseline to the third time point (a change measure that will also be computed for all endpoints; the baseline to time 3 measure being of primary clinical interest).
Spearman rank correlation will examine the significance of the association between the change in cytoplasmic staining intensity and change in pruritus as assessed by subjects with the visual analog scale, neither of which will be assumed to follow a Gaussian distribution.
For descriptive purposes only, analyses will also be performed stratified on pruritis stage at baseline (early stage I-IIA vs. late stage IIB-IVB and pruritus, mild VAS less than 40 vs. moderate to severe VAS greater than 40, up to 100).
- IL-31 amount and intensity of cathepsin S expression [ Time Frame: 6 months ]
IL31 amount and cathepsin S intensity of expression will be determined at 3 time points described above and also from itchy and non-itchy skin at each time point. The goal is to determine if there is an association between a change (presumably a decrease) in these targets and an improvement in pruritus as reported by the VAS score.
Spearman rank correlation will examine the significance of the association between the change in amount of IL-31 or level of cathepsin S expression and change in pruritus as assessed by subjects with the visual analog scale, neither of which will be assumed to follow a Gaussian distribution.
For this data, taken in separate locations (treatment, control) on the same individuals, we will perform paired t-tests or non-parametric Wilcoxon signed rank tests as appropriate.
- percentage of vasodilatory peptidergic nerves at the dermoepidermal junction as a percentage of total nerves [ Time Frame: 6 months ]
The total nerve length of all nerves and the total nerve length of nerves expressing vasodilatory peptidergic markers will be determined in the skin biopsies at 3 time points described above, and the percentage calculated.
Spearman rank correlation will examine the significance of the association between the change in the above percentage of nerves and change in pruritus as assessed by subjects with the visual analog scale, neither of which will be assumed to follow a Gaussian distribution.
For this data taken in separate locations (treatment, control) on the same individuals, we will perform paired t-tests or non-parametric Wilcoxon signed rank tests as appropriate.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801670
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Deon Wolpowitz, MD, PhD||Boston University|