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Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides
Trial ID: NCT01187446
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.
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)
- Biopsy-confirmed mycosis fungoides (MF); clinical stage IB; IIA; IIB; or IIIB.
- 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
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) of ≤ 2.
- White blood cell (WBC) > 2000/uL
- Platelet count > 75,000/mm3
- Absolute neutrophil count (ANC) > 1000.
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 x UNL
- Alanine aminotransferase (ALT) ≤ 2.5 x UNL
- Alkaline phosphatase (liver fraction) ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x UNL OR creatinine clearance ≤ 60 mL/min for patients with
creatinine levels > 1.5 x institutional ULN
- Potassium level between 3.5 and 4.5
- Magnesium level between 1.5 and 2.5
- Required washout 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).
- Women of child-bearing potential (WOCBP) must have negative serum pregnancy test.
- 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).
- Male subjects must be willing to use an appropriate method of contraception (eg,
condoms) or abstain from sexual intercourse and inform any sexual partners that they
must also use a reliable method of contraception (eg, birth control pills) during the
- Ability to understand and sign a written informed consent document.
- Ability to comply with the treatment schedule
- Prior courses of TSEBT (Note : localized skin-directed radiotherapy is allowed if
administered at least 4 weeks prior to initiation on study).
- Concomitant use of any anti-cancer therapy or immune modifier.
- Receiving colony stimulating factors.
- Prior allogeneic or autologous transplant.
- Active infection or have received intravenous antibiotics, antiviral, or antifungal
agents within 2 weeks prior to the start of the study drug.
- Known history of human immunodeficiency virus (HIV), hepatitis B or C.
- History of prior malignancy with the exception of cervical intraepithelial neoplasia,
non-melanoma skin cancer, and adequately treated localized prostate carcinoma (PSA <
1.0). Patients with a history of other malignancies must have undergone potentially
curative therapy and have no evidence of that disease for 5 years.
- Uncontrolled intercurrent illness, condition, or circumstances that could limit
compliance with the study, including, but not limited to the following: active
infection, acute or chronic graft versus host disease, symptomatic congestive heart
failure, unstable angina pectoris, medically significant cardiac arrhythmia,
uncontrolled diabetes mellitus or hypertension, or psychiatric conditions.
- Medically significant cardiac event in prior 6 months (ie, myocardial infarction,
- Congenital long QT syndrome.
- QTc interval > 480 msec on screening ECG.
- Proven or suspected stage IV disease including patients with B2 (Sezary syndrome); N3
(frank LN disease); or M1 (visceral disease) categories; presence of reactive or
dermatopathic lymphadenopathy (N1-2) or limited blood involvement (B1) is permitted.
- Pregnant or lactating.
- Unwilling to use reliable birth control methods.
- Any other medical issue, including laboratory abnormalities, deemed by the
Investigator to be likely to interfere with patient participation.
- Unwilling or unable to provide informed consent.
radiation: Total skin electron beam therapy (TSEBT)
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cutaneous Lymphoma Coordinator