Phase II/III, Multicenter, Open-label, Randomized Study Comparing Autologous Intravesical Macrophage Cell Therapy (Bexidem”) to Intravesical BCG-Therapy in Patients With Superficial Papillary Bladder Cancer Who Have Undergone Complete Transurethral Resectio

Active, not recruiting

• Conditions: BLADDER CANCER AFTER TRANSURETRHAL RESECTIO

• Registration Number: EUCTR2004-003699-13-ES
• Lead Sponsor: INMUNO DESIGNED MOLECULES (IDM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

·Male and female patients
Over 18 years of age
Fully resected papillary transitional cell carcinoma
Stage TaGI, TaGII, TaGIII, T1GI or T1GII (N0, M0)
Either of the following:
Plurifocal tumors or,
Unifocal tumor with = 2 tumor occurences within the last 24 months
WHO performance state 0-2
Normal upper urinary tract as documented by either IV urography or CT-scan
Blood creatinine < 200 µmol/L, ALT and AST < 2,5 x ULN, Leukocytes = 3,500/mm3
Able to understand and follow treatment scheme
Signed and dated Informed Consent
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

·= T1 GIII bladder cancer
Carcinoma in situ (CIS)
Active tuberculosis/Other active infection (including urinary tract infection) and/or infections that may compromise the immune system such as HIV, HTLV, Hepatitis B or Hepatitis C infection/History of other active malignancy within five years, except adequately treated basal cell and squamous cell carcinoma of the skin /Other serious illness or medical conditions (e.g. history of significant cardiac or respiratory dysfunction)
Patients with a contra-indication preventing apheresis / History of autoimmune-related disorder / Known hypersensitivity to any of the components of the study drugs (e.g. DMSO)
Immunosuppression or congenital or acquired immune deficiencies, whether due to concurrent disease (e.g. AIDS, leukaemia, lymphoma), cancer therapy (cytotoxic drugs, radiotherapy) or immunosuppressive therapy (e.g. corticosteroids, cyclosporinFamily history of Creutzfeldt-Jacob disease and/or Risk of Creutzfeldt-Jacob disease defined as patient having received extracted growth hormone or neurosurgery before 1996
Prior systemic reaction to BCG therapy
Pregnant or nursing women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified