Multicentre, randomised study comparing autologous intravesical macrophage cell therapy (Bexidem®) to intravesical Bacillus Calmette-Guerin (BCG) therapy in patients with superficial papillary bladder cancer

Completed

• Conditions: Superficial papillary bladder cancer; Cancer; Malignant neoplasm of bladder

• Registration Number: ISRCTN35881130
• Lead Sponsor: IDM Pharma SA (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified