BLADDER CANCER AFTER TRANSURETRHAL RESECTION
Conditions
Interventions
Product Name: BEXIDEM
Pharmaceutical Form: Solution for intravesical use
INN or Proposed INN: macrophage activated-killer(MAK cells)
Other descriptive name: MAK
Concentration type: range
Concentration
Sponsors
INMUNO DESIGNED MOLECULES (IDM)
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase II: To demonstrate a superior safety profile of Bexidem with respect to “Frequent Immunotherapy-Linked Adverse Events” (FILAEs) compared to BCG therapy. Phase III: To compare efficacy (recurrence-free survival) of Bexidem therapy to BCG therapy.;Secondary Objective: 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.;Primary end point(s): The two-point objectives of this trial are (i) to demonstrate a superior safety profile of BEXIDEM-therapy compared to BCG as assessed by “Frequent Immunotherapy-Linked Adverse Events” (FILAEs), and (ii) to compare the efficacy of BEXIDEM therapy to BCG-therapy as assessed by recurrence-free survival.It is intended to conduct an analysis at the end of Phase II for the Phase II primary endpoint (safety profile) and an interim analysis to determine the number of additional patients required to complete a Phase III step to compare the efficacy of BEXIDEM therapy to BCG. A decision whether to continue or to discontinue the trial will be taken at the interim point. | — |
Countries
Spain
Outcome results
None listed