A phase II study of Gemcitabine and Bexarotene (GemBex) in the treatment of cutaneous T-cell lymphoma

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Lymphoma; Disease: Lymphoma (non-Hodgkin's); Cancer; Lymphoma (non-Hodgkin's)

• Registration Number: ISRCTN18563749
• Lead Sponsor: niversity College London (UCL) (UK)

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24136145

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-31
• Study Completion: 2012-07-31
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Males or non-pregnant females aged greater than 18 years
2. Histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL), including mycosis fungoides and Sézary syndrome
3. Stage Ib, IIa, IIb, III, IVa and IVb disease
4. 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
5. Anticipated life expectancy greater than six months
6. Written informed consent to participate in the study. vii.Bexarotene naive or previous response to single-agent bexarotene, but more than 3 months since last treatment with bexarotene

Exclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status greater than 1
2. Patients who have not received at least 1 course of prior systemic therapy for CTCL
3. CD30 + (Ki1+ve) anaplastic large cell lymphoma
4. Patients who have failed previous treatment with Bexarotene (Targretin®)
5. Patients who have previously experienced a severe adverse reaction to Bexarotene
6. Concomitant use of any anti-cancer therapy
7. Concomitant use of any investigational agent
8. Use of any investigational agent within 4 weeks of study entry
9. Clinically significant active infection
10. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
11. Excessive alcohol consumption
12. Uncontrolled diabetes mellitus
13. Biliary tract disease
14. History of pancreatitis
15. Concomitant drug therapy with other medications that can elevate triglycerides or cause pancreatic toxicity e.g. Gemfibrozil
16. Inadequate bone marrow or other organ function, as evidenced by: Unsupported haemoglobin less than 9.0 g/dL (transfusions and/or erythropoietin are permitted); Absolute neutrophil count (ANC) = 1.5 x 10^9/L; Platelet count less than 100 x 10^9/L
17. Total bilirubin greater than 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) greater than 2.0 x ULN, serum creatinine greater than 2 x ULN for age and sex
18. 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)
19. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures
20. 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.
21. Any treatment for lymphoma, including photopheresis, within the 4 weeks prior to entering the study. For patients receiving long-term corticosteroid therapy, the dose should ideally be stopped and if this is not feasible reduced to as low as possible. If steroids cannot be stopped, patients who have been on stable doses less than or equal to 20 mg for at least 3 months can be entered into the study. Local radiotherapy to isolated symptomatic tumour nodules requiring immediate treatment may be given until 2 weeks prior to entering the study.
22. Warfarin

Study & Design

• Study Type: Interventional
• Study Design: Not specified