Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides
|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
The purpose of this study is to determine if vorinostat combined with low-dose total skin electron beam therapy (TSEBT) offers superior clinical benefit (efficacy & safety) over low-dose TSEBT alone in participants with mycosis fungoides (MF)
Treatment in this study is TSEBT +/- vorinostat, with participants stratified by MF stage.
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Lymphoma Cutaneous T-cell Lymphoma||Radiation: Total skin electron beam therapy (TSEBT) Drug: Vorinostat||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Randomized, Phase I/II Study Evaluating the Safety and Efficacy of Low-dose (12 Gy) Total Skin Electron Beam Therapy (TSEBT) Combined With Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides (MF)|
|Study Start Date :||December 2010|
|Primary Completion Date :||August 2013|
|Study Completion Date :||February 2014|
Experimental: TSEBT & Vorinostat
Total skin electron beam therapy (TSEBT) will be performed per institution guidelines.
Vorinostat will be administered at a dose of 400 mg/day, starting one day prior to the initiation of TSEBT. During TSEBT, vorinostat should be taken in the morning and preferably prior to TSEBT.
Radiation: Total skin electron beam therapy (TSEBT)
TSEBT is administered as 12 Gy fractionated at 2 grey (Gy)/cycle (each cycle requiring 2 days of treatment); 4 days each week; for 3 weeks.Drug: Vorinostat
Starting doses of is vorinostat 400 mg/day, continuing for 8 weeks.
Other Name: Zolinza
Active Comparator: TSEBT only
Total skin electron beam therapy (TSEBT) will be administered according to the Stanford 6-field technique or equivalent technique per institutional standards. Patients will receive a planned total skin dose of 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. Supplements will routinely be applied to the perineum and soles as well as any other "shadowed" sites involved by disease, such as the inframammary regions (1-2 Gy fractions to a total dose of 12 Gy). Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy.
Radiation: Total skin electron beam therapy (TSEBT)
TSEBT is administered as 12 Gy fractionated at 2 grey (Gy)/cycle (each cycle requiring 2 days of treatment); 4 days each week; for 3 weeks.
- Complete Clinical Response (CCR) [ Time Frame: Week 8 ]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.
- 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. ]Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm.
- Clinical Response Rate (CRR) [ Time Frame: Week 8 ]
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:
- > 25% increase in skin disease from baseline as measured by > 25% increase of mSWAT score compared with baseline
- New tumor (T3) lesions in patients without prior T3 lesions (T1, T2, T4) or
- In responders (confirmed), increase in skin disease over nadir by 50% of baseline as measured by mSWAT score of > [nadir + > 50% of baseline]
- Relapse applies to any new disease after confirmed CR
- Duration of Clinical Benefit (Per Protocol Follow-up) [ Time Frame: 48 weeks after completion of treatment ]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)
- Duration of Clinical Benefit (Supplemental Follow-up) [ Time Frame: 140 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187446
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Youn H Kim||Stanford University|