GemBex
Trial overview
A Phase II study of Gemcitabine and Bexarotene (GemBex) in the treatment of cutaneous T-cell lymphoma
Inclusion criteria
i. Males or non-pregnant females aged 18 years;
ii. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and Sézary syndrome;
iii. Patients with CTCL stages Ib, IIa, IIb, III and IVa only (see Appendix 6 of protocol). Staging is to take place within 1 month of obtaining full written informed consent;
iv. Patients who have failed standard skin-directed therapy and have had at least 1 course of prior systemic therapy, such as interferon, chemotherapy, Denileukin diftitox (Ontak®) which they have either failed to respond to or have subsequently progressed;
v. Anticipated life expectancy greater than six months;
vi. Written informed consent to participate in the study.
Exclusion criteria
i. ECOG Performance Status >1 (see Appendix 11 of protocol);
ii. Patients who have not received at least 1 course of prior systemic therapy for CTCL;
iii. CD30 + (Ki1+ve) anaplastic large cell lymphoma;
iv. Previous treatment with Bexarotene (Targretin®);
v. Visceral involvement i.e. Stage 4b disease (lymphadenopathy is allowed);
vi. Concomitant use of any anti-cancer therapy;
vii. Concomitant use of any investigational agent;
viii. Use of any investigational agent within 4 weeks of study entry;
ix. Clinically significant active infection;
x. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
xi. Excessive alcohol consumption;
xii. Uncontrolled diabetes mellitus;
xiii. Biliary tract disease;
xiv. History of pancreatitis;
xv. Concomitant drug therapy with other medications that can elevate triglycerides or cause pancreatic toxicity e.g. Gemfibrozil;
xvi. Inadequate bone marrow or other organ function, as evidenced by: Unsupported haemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted); Absolute neutrophil count (ANC) 1.5 x 109/L; Platelet count <100 x 109/L;
xvii. Total bilirubin >1.25 x upper limit of normal (ULN) for institution, aspartate transaminase/glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/ glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN, serum creatinine >2 x ULN for age and sex;
xviii. 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);
xix. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures;
xx. Patients who are pregnant or breast-feeding (all women of child-bearing potential must use the contraceptive pill or intrauterine contraceptive device (IUCD) during the treatment period and for at least 1 month thereafter). Male patients must use a barrier method of contraception during the treatment period and for at least 1 month thereafter;
xxi. Any treatment for lymphoma within the 4 weeks prior to entering the study, with the exception of topical steroids and local radiotherapy to isolated symptomatic tumour nodules requiring immediate treatment, which may be given until 2 weeks prior to entering the study;
xxii. Warfarin.