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.

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.

• 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 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.
Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.

TSEBT Plus Vorinostat

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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.

Clinical Stage

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.

Complete Clinical Response (CCR)

Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm.

Safety and Tolerability as Measured by Severity and Frequency of Adverse Events

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

Clinical Response Rate (CRR)

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 (Per Protocol Follow-up)

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.

Duration of Clinical Benefit (Supplemental Follow-up)

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.

Overall Study

Youn H Kim, MD

TSEBT (12Gy) per institutional guidelines.

TSEBT (12Gy) per institutional guidelines.
Vorinostat 400 mg daily starting one day prior to the initiation of TSEBT.

TSEBT & Vorinostat

Cutaneous Lymphoma

Cutaneous T-cell Lymphoma

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.

Total skin electron beam therapy (TSEBT)

Starting doses of is vorinostat 400 mg/day, continuing for 8 weeks.

Vorinostat

Stanford University School of Medicine

Yale University School of Medicine

MD Anderson Cancer Center

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

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)

mycosis fungoides/fatigue

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

Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası