A single agent Phase II study of depsipeptide (FK228) in the treatment of Cutaneous T-cell lymphoma - Depsipeptide in CTC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

•Males or non-pregnant females aged ?18 years.
•Histologically confirmed diagnosis of CTCL, including mycosis fungoides and Sézary syndrome.
•Patients with CTCL stages IIa, IIb, III and IVa
•Patients with CTCL stage Ib who have relapsed following previous therapy and where, in the investigator’s opinion, the potential benefit of treatment with FK228 outweighs the possible risks.
•Patients who have failed standard skin-directed therapy and have had at least one course of systemic therapy, such as interferon, which they have been deemed to have failed.
•Anticipated life expectancy greater than six months.
•Written informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•ECOG Performance Status > 1 (see Appendix H).
•Patients who have not received at least 1 course of prior systemic therapy for CTCL.
•Visceral involvement i.e. Stage 4b disease (lymphadenopathy is allowed).
•Patients with known cardiac abnormalities such as:-
Congenital long QT syndrome
QTc interval > 480 milliseconds
Any cardiac arrhythmia requiring anti-arrhythmic medication.
•Patients who have had a myocardial infarction within 12 months of study entry.
•Patients who have a history of coronary artery disease (CAD) e.g. angina Canadian class II to IV (Appendix N). In any patient in whom there is doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.
•Patients with an ECG recorded at screening showing evidence of cardiac ischaemia (ST depression of ?2 mm). If in any doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.
•Patients with congestive heart failure that meets New York Heart Association class II to IV definitions (Appendix O) and/or ejection fraction <40% by multiple gated acquisition (MUGA) scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI)
•Patients with a 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).
•Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above).
•Patients with uncontrolled hypertension, i.e. ?160/95 mmHg.
•Concomitant use of any anti-cancer therapy. (For study eligibility, a one month washout period is required before treatment with depsipeptide is started for patients who have received radiotherapy or psoralen plus ultraviolet A (PUVA) therapy.)
•Concomitant use of warfarin.
•Concomitant use of any investigational agent.
•Use of any investigational agent within 4 weeks before treatment with depsipeptide is started.
•Concomitant use of drugs which may cause a prolongation of the QTc interval. (For study eligibility, a washout period of at least 5 half-lives must elapse before treatment with depsipeptide is started. A list of half lives is provided in Appendix F.)
•Patients with a potassium level of <3.5 mmol/L and a magnesium level of <0.8 mmol/L.
•Clinically significant active infection.
•Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
•Inadequate bone marrow or other organ function, as evidenced by:
ounsupported haemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted);
oabsolute neutrophil count (ANC) oplatelet count <100 x 109/L;
ototal bilirubin >1.25 x upper limit of normal (ULN) for institution;
oaspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN, serum creatinine >2 x ULN for age and sex.
•Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin or cervical epithelial neoplasm [CIN1, carcinoma in situ] that has been treated curatively).
•Any significant medical or psychiatric condition that might prevent the patient from complying with all study proced

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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