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
  Purpose

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.


Condition Intervention Phase
Cutaneous Lymphoma
Cutaneous T-cell Lymphoma
Procedure: TSEBT
Drug: Vorinostat
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: December 2010
Study Completion Date: February 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TSEBT & Vorinostat Procedure: TSEBT
12Gy
Other Name: total skin electron beam therapy
Drug: Vorinostat
Calculated per patient
Other Name: Zolinza

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187446

Locations
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
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Youn H Kim Stanford University
  More Information

No publications provided

Responsible Party: Youn Kim, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01187446     History of Changes
Other Study ID Numbers: LYMNHL0078, SU-08092010-6685
Study First Received: August 20, 2010
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Cutaneous T-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Mycosis Fungoides
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014