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)
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Vorinostat
- procedure : TSEBT
Phase: Phase 1/Phase 2
Ages Eligible For Study:
A patient will be eligible for inclusion only if all of the following criteria apply: 1. Biopsy-confirmed mycosis fungoides, clinical stage IB-IIIB. 2. Patients must have failed or have been intolerant to at least one prior systemic or skin-directed therapy. This may include topical steroids if used as primary therapy for MF. 3.18 years of age or older. 4.Eastern Cooperative Oncology Group (ECOG) of <= 2. 5.Adequate bone marrow function: WBC > 2000/uL; platelet count > 75,000/mm3; ANC > 1000. Patients cannot be using colony stimulating factors. 6.Required wash out period for prior therapies - Topical therapy: 2 weeks - Systemic biologic, monoclonal antibody, or chemotherapy: 4 weeks - Phototherapy or radiotherapy (excluding TSEBT): 4 weeks - Other investigational therapy: 4 weeks - Note: patients with rapidly progressive disease may be treated earlier than required washout period; however, such circumstance must be discussed and approved by the protocol director at the primary site (Stanford). 7.Women of child-bearing potential (WOCBP) must have negative serum pregnancy test. 8.WOCBP must agree to use effective contraception, defined as oral contraceptives, intrauterine devices, double barrier method (condom plus spermicide or diaphragm) or abstain from sexual intercourse. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for 12 consecutive months). 9.Male subjects must be willing to use an appropriate method of contraception (e.g., condoms) or abstain from sexual intercourse and inform any sexual partners that they must also use a reliable method of contraception (e.g., birth control pills) during the study. 10.Adequate hepatic function: bilirubin <= 1.5 x upper limit of normal (ULN), AST <= 2.5 x UNL, ALT <= 2.5 x UNL, alkaline phosphatase (liver fraction) <= 2.5 x ULN 11.Adequate renal function: creatinine <=1.5 x UNL OR creatinine clearance <=60 mL/min for patients with creatinine levels > 1.5 X institutional ULN 12.Metabolic parameters: potassium level between 3.5 and 4.5, magnesium level between 1.5 and 2.5 13.Ability to understand and sign a written informed consent document. 14.Ability to comply with the treatment schedule