Phase II/III, multicentre, open-label, randomised study comparing autologous intravesical macrophage cell therapy (Bexidem®) to intravesical Bacillus Calmette-Guerin (BCG) therapy in patients with superficial papillary bladder cancer who have undergone complete transurethral resection

IDM Pharma SA (France)0 个研究点目标入组 650 人开始时间: 2009年5月27日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Male and female patients
•2. At least 18 years of age
•3. Fully resected papillary transitional cell carcinoma
•4. Stage TaGI, TaGII, TaGIII, T1GI or T1GII (N0, M0)
•5. Either of the following:
•5.1. Plurifocal tumours
•5.2. Unifocal tumour provided greater than or equal to two tumour occurrences within the last 24 months
•6. World Health Organization (WHO) performance status 0 - 2
•7. Normal upper urinary tract as documented by intravenous (IV) urography or computed tomography (CT) scan
•8. Blood creatinine less than 200 umol/L
•9. Alanine aminotransferase (ALT) and aspartate aminotrasferase (AST) less than 2.5 x upper limit of normal (ULN)
•10. Leukocytes greater than or equal to 3,500/mm^3
•11. Able to understand and follow treatment scheme
•12. Signed and dated Informed Consent

•1. Greater than or equal to T1GIII bladder cancer
•2. Carcinoma in situ (CIS)
•3. Active tuberculosis
•4. Other active infection (including urinary tract infection) and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B or hepatitis C infection
•5. History of other active malignancy within five years, except adequately treated basal cell and squamous cell carcinoma of the skin
•6. Other serious illness or medical conditions (e.g. history of significant cardiac or respiratory dysfunction)
•7. Patients with a contra-indication preventing apheresis
•8. History of autoimmune-related disorder
•9. Known hypersensitivity to any of the components of the study drugs (e.g. dimethylsulphoxide [DMSO])
•10. Immunosuppression or congenital or acquired immune deficiencies, whether due to concurrent disease (e.g. acquired immune deficiency syndrome [AIDS], leukaemia, lymphoma), cancer therapy (cytotoxic drugs, radiotherapy) or immunosuppressive therapy (e.g. corticosteroids, cyclosporin)
•11. Family history of Creutzfeldt-Jacob disease and/or risk of Creutzfeldt-Jacob disease defined as patient having received extracted growth hormone or neurosurgery before 1996
•12. Prior systemic reaction to BCG therapy
•13. Pregnant or nursing women

发起方

IDM Pharma SA (France)