Vorinostat in Patients With Primary Cutaneous T-Cell Lymphoma

This study has been terminated.
(Terminated due to slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00958074
First received: August 10, 2009
Last updated: December 11, 2014
Last verified: December 2014
Results First Received: December 4, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cutaneous T-cell Lymphoma Stage I
Cutaneous T-cell Lymphoma Stage II
Cutaneous T-cell Lymphoma Stage III
Cutaneous T-cell Lymphoma Stage IV
Interventions: Drug: vorinostat
Other: flow cytometry
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Cohort I (>=65 Years Old)

200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.

vorinostat: Given PO

flow cytometry: correlative study

laboratory biomarker analysis: correlative study

Cohort II (<65 Years Old)

400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.

vorinostat: Given PO

flow cytometry: correlative study

laboratory biomarker analysis: correlative study


Participant Flow:   Overall Study
    Cohort I (>=65 Years Old)     Cohort II (<65 Years Old)  
STARTED     4     7  
COMPLETED     4     6  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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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
Cohort I (>=65 Years Old)

200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.

vorinostat: Given PO

flow cytometry: correlative study

laboratory biomarker analysis: correlative study

Cohort II (<65 Years Old)

400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.

vorinostat: Given PO

flow cytometry: correlative study

laboratory biomarker analysis: correlative study

Total Total of all reporting groups

Baseline Measures
    Cohort I (>=65 Years Old)     Cohort II (<65 Years Old)     Total  
Number of Participants  
[units: participants]
  4     7     11  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     7     7  
>=65 years     4     0     4  
Gender  
[units: participants]
     
Female     2     3     5  
Male     2     4     6  



  Outcome Measures

1.  Primary:   Objective Response   [ Time Frame: After at least 14 days. With Confirmation after additional 28 days. ]

2.  Secondary:   Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);   [ Time Frame: Up to 30 days post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Safety and Tolerability of Dose-adjusted Vorinostat   [ Time Frame: Up to 30 days post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Changes in Sezary Cell Count Measured by Serial Flow Cytometry Measurements   [ Time Frame: Baseline to 30 days post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in the Physicians Serial Assessment of Erythroderma Score   [ Time Frame: Baseline to 30 days post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Early termination leading to small numbers of subjects analyzed


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Andrei Shustov
Organization: University of Washington
phone: 206-288-6744
e-mail: ashustov@uw.edu


No publications provided


Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00958074     History of Changes
Other Study ID Numbers: 6914, NCI-2009-01231
Study First Received: August 10, 2009
Results First Received: December 4, 2013
Last Updated: December 11, 2014
Health Authority: United States: Institutional Review Board