Superficial papillary bladder cancer Cancer Malignant neoplasm of bladder
Conditions
Interventions
Dosage and administration:
Three treatment cycles: first cycle consists of either 6 weekly Bexidem® instillations (0.5 - 2 x 10^8 cells in a total volume of 50 ml per instillation) or BCG instillati
Sponsors
IDM Pharma SA (France)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: To demonstrate a superior safety profile of Bexidem® with respect to FILAEs compared to BCG therapy. Phase III: To compare efficacy (recurrence-free survival) of Bexidem® therapy to BCG therapy. The comparison of toxicity will be performed after all patients in the Phase II step have completed all cycles of treatment and at least three months of follow up (month 9). The recurrence-free survival in each group will be estimated after all Phase II patients have completed at least six months of follow up after the last treatment (month 12 visit). These analyses will serve as the basis for a decision to proceed to the Phase III step as well as to estimate the expected recurrence-free survival in the two groups and recalculate the sample size required for the Phase III step. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: To evaluate overall efficacy and recurrence-free survival in patients treated with Bexidem® therapy. Phase III: To evaluate overall safety of Bexidem® therapy as compared to BCG. The comparison of toxicity will be performed after all patients in the Phase II step have completed all cycles of treatment and at least three months of follow up (month 9). The recurrence-free survival in each group will be estimated after all Phase II patients have completed at least six months of follow up after the last treatment (month 12 visit). These analyses will serve as the basis for a decision to proceed to the Phase III step as well as to estimate the expected recurrence-free survival in the two groups and recalculate the sample size required for the Phase III step. | — |
Countries
Belgium, France, Germany, Hungary, Luxembourg, Spain
Outcome results
None listed