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Romidepsin in Treating Patients With Steroid-Refractory Graft-versus-Host Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203578
Recruitment Status : Terminated (slow accrual)
First Posted : July 30, 2014
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Brief Summary:
This pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Drug: romidepsin Other: laboratory biomarker analysis Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if romidepsin should be developed as a therapy for patients with steroid-refractory GVHD.

OUTLINE:

Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 and 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Romidepsin for Therapy of Graft-versus-Host Disease
Study Start Date : November 2014
Actual Primary Completion Date : June 14, 2016
Actual Study Completion Date : June 14, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Romidepsin

Arm Intervention/treatment
Experimental: Supportive care (romidepsin)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: romidepsin
Given IV
Other Names:
  • FK228
  • FR901228
  • Istodax

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Incidence of aGVHD [ Time Frame: At 28 days after initiation of romidepsin ]
  2. Incidence of cGVHD [ Time Frame: At 1 month after initiation of romidepsin ]
  3. Incidence of cGVHD [ Time Frame: At 3 months after initiation of romidepsin ]
  4. Incidence of cGVHD [ Time Frame: At 6 months after initiation of romidepsin ]
  5. Incidence of cGVHD [ Time Frame: At 9 months after initiation of romidepsin ]
  6. Incidence of cGVHD [ Time Frame: At 12 months after initiation of romidepsin ]

Secondary Outcome Measures :
  1. Total Duration of Immunosuppressive Therapy [ Time Frame: Up to 12 months after initiation of romidepsin ]
  2. Rate of Documented Infection [ Time Frame: Up to 12 months after initiation of romidepsin ]
  3. T Cell Kinetics - Reconstitution [ Time Frame: Up to 12 months after initiation of romidepsin ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with steroid (or immunosuppressive therapy [IST]) refractory acute GVHD (aGVHD) or chronic GVHD (cGVHD)
  • Absolute neutrophil count >= 750/mm^3
  • Platelet count >= 50,000/mm^3
  • Corrected QT interval (QTc) =< 480 msec
  • Bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN
  • Serum potassium >= 3.8 mmol/L
  • Serum magnesium >= 1.8 mg/dL
  • Serum creatinine =< 2.0 mg/dl
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
  • Patients may undergo electrolyte repletion therapy to meet eligibility requirements
  • Patients must be scheduled for tapering doses of (or no longer treated with):

    • Cyclosporine;
    • Tacrolimus;
    • Sirolimus;
    • Steroids (patients may be on physiologic doses of steroids)
  • Patients receiving extracorporeal photopheresis must discontinue extracorporeal photopheresis or placed on a tapering schedule;
  • Any prior therapy for GVHD must be completed and discontinued with the exception of the above;
  • Patients with breakpoint cluster region (bcr)-ABL proto-oncogene 1 (abl) associated malignancies may be on a tyrosine kinase inhibitor as malignant disease therapy or prophylaxis
  • There must be no uncontrolled active infections or medical conditions that the investigator feels will compromise the safety of the treatment and/or the assessment of the efficacy of therapy
  • The patient must be aware of the high risk and experimental nature of the treatment and provide informed consent
  • Negative serum pregnancy test at the time of enrollment for females of childbearing potential
  • For males and females of child-producing potential, use of effective contraceptive methods during the study and for at least 6 months after the last dose of romidepsin

Exclusion Criteria:

  • Active/uncontrolled infection
  • Evidence of relapsed disease
  • Life expectancy < 12 weeks
  • Pregnant or breast feeding females
  • Prior therapy with romidepsin
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of hepatitis B virus vaccine are eligible
  • Any known cardiac abnormalities such as:

    • Congenital long QT syndrome
    • QTc interval >= 480 milliseconds;
    • Myocardial infarction within 6 months of course 1, day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;
    • Other significant electrocardiogram (ECG) abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);
    • Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
    • An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
    • Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or ejection fraction < 40% by multi gated acquisition (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI);
    • A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
    • Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other cause;
    • Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
  • Uncontrolled hypertension, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or
  • Patients taking drugs leading to significant QT prolongation must have an ECG prior to each treatment
  • Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
  • Concomitant use of medications known to induce a disulfiram-like reaction to alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203578


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
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Principal Investigator: Roger Strair Rutgers Cancer Institute of New Jersey
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Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02203578    
Other Study ID Numbers: 021309
NCI-2014-01411 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
021309 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
Pro2014004116 ( Other Identifier: IRB number )
First Posted: July 30, 2014    Key Record Dates
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents