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Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides

This study has been terminated.
(Business decision by funding source)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187446
First Posted: August 24, 2010
Last Update Posted: November 20, 2017
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.
Information provided by (Responsible Party):
Youn Kim, Stanford University
Results First Submitted: December 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cutaneous Lymphoma
Cutaneous T-cell Lymphoma
Interventions: Radiation: Total skin electron beam therapy (TSEBT)
Drug: Vorinostat

  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
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Reporting Groups
  Description
TSEBT Only • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
TSEBT Plus Vorinostat
  • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
  • Vorinostat 400 mg/day continuing for 8 weeks total.

Participant Flow:   Overall Study
    TSEBT Only   TSEBT Plus Vorinostat
STARTED   14   14 
COMPLETED   14   13 
NOT COMPLETED   0   1 
Patient started non-protocol therapy                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.
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Reporting Groups
  Description
TSEBT Only • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
TSEBT Plus Vorinostat
  • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.
  • Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.
Total Total of all reporting groups

Baseline Measures
   TSEBT Only   TSEBT Plus Vorinostat   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   28 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      9  64.3%      12  85.7%      21  75.0% 
>=65 years      5  35.7%      2  14.3%      7  25.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  50.0%      6  42.9%      13  46.4% 
Male      7  50.0%      8  57.1%      15  53.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   7.1%      2  14.3%      3  10.7% 
Not Hispanic or Latino      10  71.4%      11  78.6%      21  75.0% 
Unknown or Not Reported      3  21.4%      1   7.1%      4  14.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   0   0   0 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   3   2   5 
White   10   10   20 
More than one race   0   0   0 
Unknown or Not Reported   1   1   2 
Clinical Stage [1] 
[Units: Participants]
Count of Participants
     
Mycosis fungoides, Stage IB      9  64.3%      8  57.1%      17  60.7% 
Mycosis fungoides, Stage IIA      2  14.3%      2  14.3%      4  14.3% 
Mycosis fungoides, Stage IIB      2  14.3%      3  21.4%      5  17.9% 
Mycosis fungoides, Stage IIIB      1   7.1%      1   7.1%      2   7.1% 
[1]

Participants are stratified by MF stage as follows.

  • Stage IB: ~10 % skin involvement, with up to 1000/mm3 clone+ Sezary cells in blood. No abnormal lymph nodes.
  • Stage IIA: Up to 10% skin involvement, with up to 1000/mm3 clone+ Sezary cells in blood & clinically abnormal peripheral lymph nodes.
  • Stage IIB: One or more tumors 1 cm in diameter, with up to 1000/mm3 clone+ Sezary cells in blood & clinically abnormal peripheral lymph nodes.
  • Stage IIIB: Skin erythema >80 % body surface area, with up to 1000/mm3 clone+ Sezary cells in blood & clinically abnormal peripheral lymph nodes.


  Outcome Measures
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1.  Primary:   Complete Clinical Response (CCR)   [ Time Frame: Week 8 ]

2.  Secondary:   Safety and Tolerability as Measured by Severity and Frequency of Adverse Events   [ Time Frame: Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first. ]

3.  Secondary:   Clinical Response Rate (CRR)   [ Time Frame: Week 8 ]

4.  Secondary:   Duration of Clinical Benefit (Per Protocol Follow-up)   [ Time Frame: 48 weeks after completion of treatment ]

5.  Secondary:   Duration of Clinical Benefit (Supplemental Follow-up)   [ Time Frame: 140 weeks ]


  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
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  More Information
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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: Youn H Kim, MD
Organization: Stanford University Medical Center
phone: 650-521-3545
e-mail: younkim@stanford.edu


Publications:

Responsible Party: Youn Kim, Stanford University
ClinicalTrials.gov Identifier: NCT01187446     History of Changes
Other Study ID Numbers: IRB-18417
SU-08092010-6685 ( Other Identifier: Stanford University )
LYMNHL0078 ( Other Identifier: OnCore )
First Submitted: August 20, 2010
First Posted: August 24, 2010
Results First Submitted: December 28, 2016
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017