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

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ClinicalTrials.gov Identifier: NCT01187446
Recruitment Status : Terminated (Business decision by funding source)
First Posted : August 24, 2010
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Youn Kim, Stanford University

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
Enrollment 28

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TSEBT Only TSEBT Plus Vorinostat
Hide Arm/Group Description • 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 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.
Period Title: Overall Study
Started 14 14
Completed 14 13
Not Completed 0 1
Reason Not Completed
Patient started non-protocol therapy             0             1
Arm/Group Title TSEBT Only TSEBT Plus Vorinostat Total
Hide Arm/Group Description • 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 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 of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
6
  42.9%
13
  46.4%
Male
7
  50.0%
8
  57.1%
15
  53.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 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]
Measure Description:

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.
1.Primary Outcome
Title Complete Clinical Response (CCR)
Hide Description Complete Clinical Response (CCR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0. mSWAT is an objective, quantitative, severity-weighted method to assess the extent of mycosis fungoides (MF) lesions, and is determined by total body surface area (%TBSA) of the lesion by a severity-weighting factor (1 = patch; 2 = plaque; 4 = tumor). O% TBSA produces a product of 0, indicating complete response.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSEBT Only TSEBT Plus Vorinostat
Hide Arm/Group Description:
• 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 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.
Overall Number of Participants Analyzed 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
3
  21.4%
3
  23.1%
2.Secondary Outcome
Title Safety and Tolerability as Measured by Severity and Frequency of Adverse Events
Hide Description Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSEBT Only TSEBT Plus Vorinostat
Hide Arm/Group Description:
• 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 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.
Overall Number of Participants Analyzed 14 13
Measure Type: Number
Unit of Measure: Number of patients
Alopecia 7 10
Fatigue 4 10
Extremity Pain 9 6
Nausea 0 8
Dysgeusia 0 4
Nail Changes 4 1
Diarrhea 0 3
Ocular Irritation 0 3
Radiation Dermatitis 1 3
Thrombocytopenia 0 3
Anorexia 0 2
Dizziness 0 2
Lymphopenia 0 2
Pedal Edema 2 1
Skin Pain 1 2
Vomiting 0 2
Xerosis/Dry Skin 1 2
3.Secondary Outcome
Title Clinical Response Rate (CRR)
Hide Description

Clinical Response Rate (CRR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0, consisting of complete response (CR) rate; partial response (PR) rate; stable disease (SD) rate; or progressive disease (PD) rate.

CR = 100% clearance of skin disease (mSWAT score = 0) PR = 50%to <100% clearance of skin disease as measured by > 50% decrease of mSWAT score compared with baseline SD = Not CR, PR, or PD

PD = Whichever is met first of:

  1. > 25% increase in skin disease from baseline as measured by > 25% increase of mSWAT score compared with baseline
  2. New tumor (T3) lesions in patients without prior T3 lesions (T1, T2, T4) or
  3. In responders (confirmed), increase in skin disease over nadir by 50% of baseline as measured by mSWAT score of > [nadir + > 50% of baseline]
  4. Relapse applies to any new disease after confirmed CR
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSEBT Only TSEBT Plus Vorinostat
Hide Arm/Group Description:
• 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 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.
Overall Number of Participants Analyzed 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
3
  21.4%
3
  23.1%
Partial Response
8
  57.1%
10
  76.9%
Stable Disease
3
  21.4%
0
   0.0%
Progressive Disease
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Duration of Clinical Benefit (Per Protocol Follow-up)
Hide Description Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment until progressive disease, as measured by the mSWAT skin assessment, and censored at the final per-protocol assessment (48 weeks)
Time Frame 48 weeks after completion of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data are reported for the per-protocol period of follow-up (48 weeks).
Arm/Group Title TSEBT Only TSEBT Plus Vorinostat
Hide Arm/Group Description:
• 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 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.
Overall Number of Participants Analyzed 14 13
Median (Full Range)
Unit of Measure: Weeks
48
(9.6 to 48)
28
(5.7 to 48)
5.Secondary Outcome
Title Duration of Clinical Benefit (Supplemental Follow-up)
Hide Description Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment or until progressive disease, as measured by the mSWAT skin assessment.
Time Frame 140 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data are reported for the full period for which participant data are available.
Arm/Group Title TSEBT Only TSEBT Plus Vorinostat
Hide Arm/Group Description:
• 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 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.
Overall Number of Participants Analyzed 14 13
Median (Full Range)
Unit of Measure: weeks
125
(9.6 to 135.1)
28
(5.7 to 82.0)
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TSEBT Only TSEBT & Vorinostat
Hide Arm/Group Description TSEBT (12Gy) per institutional guidelines.

TSEBT (12Gy) per institutional guidelines.

Vorinostat 400 mg daily starting one day prior to the initiation of TSEBT.

All-Cause Mortality
TSEBT Only TSEBT & Vorinostat
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TSEBT Only TSEBT & Vorinostat
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/14 (0.00%)    
Gastrointestinal disorders     
Constipation * 1  1/14 (7.14%)  1 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TSEBT Only TSEBT & Vorinostat
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/14 (100.00%)      14/14 (100.00%)    
Blood and lymphatic system disorders     
Anemia * 1  0/14 (0.00%)  1/14 (7.14%) 
Elevated Bilirubin * 1  0/14 (0.00%)  1/14 (7.14%) 
Elevated Creatinine * 1  0/14 (0.00%)  1/14 (7.14%) 
Hypomagnesemia * 1  1/14 (7.14%)  1/14 (7.14%) 
Hyponatremia * 1  0/14 (0.00%)  1/14 (7.14%) 
Leucopenia * 1  1/14 (7.14%)  0/14 (0.00%) 
Lymphopenia * 1  0/14 (0.00%)  2/14 (14.29%) 
Neutropenia * 1  0/14 (0.00%)  1/14 (7.14%) 
Thrombocytopenia * 1  0/14 (0.00%)  3/14 (21.43%) 
Eye disorders     
Ocular Irritation * 1  0/14 (0.00%)  3/14 (21.43%) 
General disorders     
Constipation * 1  0/14 (0.00%)  1/14 (7.14%) 
Diarrhea * 1  0/14 (0.00%)  3/14 (21.43%) 
Dizziness * 1  0/14 (0.00%)  2/14 (14.29%) 
Dry Mouth * 1  0/14 (0.00%)  1/14 (7.14%) 
Dysgeusia * 1  0/14 (0.00%)  4/14 (28.57%) 
Dyspepsia * 1  0/14 (0.00%)  1/14 (7.14%) 
Extremity Pain * 1  9/14 (64.29%)  10/14 (71.43%) 
Eye Pain * 1  0/14 (0.00%)  1/14 (7.14%) 
Fatigue * 1  4/14 (28.57%)  10/14 (71.43%) 
Jaw Pain * 1  0/14 (0.00%)  1/14 (7.14%) 
Nail Changes * 1  4/14 (28.57%)  1/14 (7.14%) 
Nausea * 1  0/14 (0.00%)  8/14 (57.14%) 
Oral Pain (Lips/Cheilitis) * 1  1/14 (7.14%)  0/14 (0.00%) 
Oral Ulcer * 1  1/14 (7.14%)  0/14 (0.00%) 
Pedal Edema * 1  2/14 (14.29%)  1/14 (7.14%) 
Vomiting * 1  0/14 (0.00%)  2/14 (14.29%) 
Psychiatric disorders     
Anorexia * 1  0/14 (0.00%)  2/14 (14.29%) 
Skin and subcutaneous tissue disorders     
Abscess of Head and Neck * 1  1/14 (7.14%)  0/14 (0.00%) 
Actinic Keratosis * 1  1/14 (7.14%)  0/14 (0.00%) 
Alopecia * 1  7/14 (50.00%)  10/14 (71.43%) 
Blistering of Feet * 1  1/14 (7.14%)  1/14 (7.14%) 
Blistering of Lip * 1  0/14 (0.00%)  1/14 (7.14%) 
Hyperpigmentation * 1  0/14 (0.00%)  1/14 (7.14%) 
Peeling of Skin on Limbs * 1  1/14 (7.14%)  1/14 (7.14%) 
Pruritus * 1  1/14 (7.14%)  0/14 (0.00%) 
Radiation Dermatitis * 1  1/14 (7.14%)  3/14 (21.43%) 
Skin Infection * 1  1/14 (7.14%)  1/14 (7.14%) 
Skin Pain * 1  1/14 (7.14%)  2/14 (14.29%) 
Skin Ulceration * 1  1/14 (7.14%)  0/14 (0.00%) 
Urticaria * 1  0/14 (0.00%)  1/14 (7.14%) 
Xerosis/Dry Skin * 1  1/14 (7.14%)  2/14 (14.29%) 
Gynecomastia * 1  0/14 (0.00%)  1/14 (7.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
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