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

NCT02203578 | Terminated Results

• 4 other identifiers: 021309NCI-2014-01411P30CA072720Pro2014004116
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (6)

• Incidence of aGVHD

  At 28 days after initiation of romidepsin

• Incidence of cGVHD

  At 1 month after initiation of romidepsin

• Incidence of cGVHD

  At 3 months after initiation of romidepsin

• Incidence of cGVHD

  At 6 months after initiation of romidepsin

• Incidence of cGVHD

  At 9 months after initiation of romidepsin

• Incidence of cGVHD

  At 12 months after initiation of romidepsin

Secondary Outcomes (3)

• Total Duration of Immunosuppressive Therapy

  Up to 12 months after initiation of romidepsin

• Rate of Documented Infection

  Up to 12 months after initiation of romidepsin

• T Cell Kinetics - Reconstitution

  Up to 12 months after initiation of romidepsin

Study Arms (1)

Supportive care (romidepsin)

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

romidepsin DRUG

Given IV

Also known as: FK228, FR901228, Istodax

Supportive care (romidepsin)

laboratory biomarker analysis OTHER

Correlative studies

Supportive care (romidepsin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Roger Strair, MD, PhD
• Organization: Rutgers Cancer Institute of New Jersey

strairrk@cinj.rutgers.edu

732-235-7298

Study Officials

• Roger Strair

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: November 1, 2014
• Primary Completion: June 14, 2016
• Study Completion: June 14, 2016
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Locations

US (1)