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 Resection

INMUNO DESIGNED MOLECULES (IDM)0 sites650 target enrollmentMay 19, 2005

Overview

No summary available.

Registry

who.int

Start Date

May 19, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

INMUNO DESIGNED MOLECULES (IDM)

•·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

•·\= 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