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

This study has been terminated.
(Business decision)
Sponsor:
Information provided by (Responsible Party):
Youn Kim, Stanford University
ClinicalTrials.gov Identifier:
NCT01187446
First received: August 20, 2010
Last updated: March 7, 2014
Last verified: March 2014

August 20, 2010
March 7, 2014
December 2010
August 2013   (final data collection date for primary outcome measure)
  • Clinical response rate, especially complete response (CR) at week 8 as determined by an mSWAT score of 0 [ Time Frame: at week 8 from the first treatment day ] [ Designated as safety issue: No ]
  • Safety and tolerability as measured by severity and frequency of adverse events [ Time Frame: at week 8 from the first treatment day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01187446 on ClinicalTrials.gov Archive Site
  • To determine duration of response and time to progression as measured by the mSWAT skin assessment [ Time Frame: at week 8 from the first treatment day ] [ Designated as safety issue: No ]
  • To determine pruritus response as measured by pruritus visual analog scale (VAS) Outcome Time Frame: at week 8 from the first treatment day. (Change of 3 points for more than 4 weeks will be determined to be statistically significant. [ Time Frame: at week 8 from the first treatment day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cutaneous Lymphoma
  • Cutaneous T-cell Lymphoma
  • Procedure: TSEBT
    12Gy
    Other Name: total skin electron beam therapy
  • Drug: Vorinostat
    Calculated per patient
    Other Name: Zolinza
Experimental: TSEBT & Vorinostat
Interventions:
  • Procedure: TSEBT
  • Drug: Vorinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
28
February 2014
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

A patient will not be eligible for inclusion if any of the following criteria apply:

  1. Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study).
  2. Concomitant use of any anti-cancer therapy or immune modifier.
  3. Prior allogeneic or autologous transplant.
  4. Active infection or have received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug.
  5. Known history of human immunodeficiency virus (HIV), hepatitis B or C.
  6. 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 five years.
  7. Patient has 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.
  8. Recent (in the past 6 months) medically significant cardiac event (i.e. myocardial infarction, cardiac surgery.
  9. Congenital long QT syndrome.
  10. QTc interval > 480 msec on screening ECG.
  11. 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.
  12. ECOG performance status >2.
  13. Pregnant or lactating.
  14. Unwilling to use reliable birth control methods.
  15. Any other medical issue, including laboratory abnormalities, deemed by the Investigator to be likely to interfere with patient participation.
  16. Unwilling or unable to provide informed consent.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01187446
LYMNHL0078, SU-08092010-6685
Yes
Youn Kim, Stanford University
Stanford University
Not Provided
Principal Investigator: Youn H Kim Stanford University
Stanford University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP