Recurrent Malignant Neoplasm of Bladder
Conditions
Interventions
A total of 20 patients, aged 18-95 years, with recurrent non-muscle invasive bladder cancer and non-responders to Bacillus Calmette-Guérin (BCG) treatment considered eligible, will receive intravesica
serum levels of: sodium
Drug
Sponsors
Universidade Estadual de Campinas (UNICAMP)
Hospital Municipal de Paulínia (HMP)
Eligibility
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: Patients, 18- to 95-year-old, with BCG-refractory and relapsed non-muscle invasive bladder cancer. In addition, patients refractory to approved first and second line chemotherapy, who are at increased risk of progression to muscle invasive and / or metastatic disease, will be included. Acceptance of the Informed Consent Form (TCLE); multiple (greater than two lesions) and / or recurrent and / or large (greater than 3 cm) tumors TaG1-2; non-muscle invasive tumor (pT1); presence of carcinoma in situ (Cis); urothelial carcinoma of the bladder grade 3.
Exclusion criteria
Exclusion criteria: Patients with bladder lesion suspected of malignant neoplasm and who were not previously submitted to Transurethral Resection (TUR), ie, treatment-naive patients for the bladder tumor. Histology: adenocarcinoma, squamous cell carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the increase in relapse-free survival (RFS) and progression-free survival (PFS) in Bacillus Calmette-Guérin (BCG)-Refractory and Relapsed Non-Muscle Invasive Bladder Cancer patients, submitted to OncoTherad immunotherapy. Recurrence will be defined as histologically proven tumor recurrence. Tumor progression will be defined as tumor recurrence in histological grade higher than the initial diagnosis. The recurrence and progression of the disease will be evaluated through urinary cytology, urinary-volume ultrasound and cystoscopy every three months in the first year, in the second year and in the second year after the third year (follow-up), with biopsies semesters. Cox regression models will be used to evaluate relapse-free survival and progression. The level of significance considered in the analyzes will be 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of OncoTherad immunotherapy on the modulation of the immune system signaling pathways through immunohistochemical analyzes of urinary bladder biopsies of patients with recurrent non-muscle invasive bladder cancer who were not responsive to Bacillus Calmette-Guérin (BCG) treatment. Urinary bladder biopsies from the 20 patients will be performed every six months throughout the 3-year follow-up. Ordinal logistic regression models will be used to compare patients to immunohistochemical markers. The level of significance considered in the analyzes will be 5%.;To evaluate the safety of OncoTherad immunotherapy through the analysis of possible local and / or systemic toxic effects in Bacillus Calmette-Guérin (BCG)-Refractory and Relapsed Non-Muscle Invasive Bladder Cancer patients, during 3 years of follow-up. For this, samples of blood and urine will be collected for the following evaluations: blood count; coagulogram; serum levels of: sodium / potassium, glucose, glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase, gamma glutamyl transpeptidase, urea, creatinine; urine I; creatinine clearance; proteins in the urine. The continuous numerical epidemiological variables of the 20 patients will be evaluated by position and dispersion measures: arithmetic mean, standard deviation, minimum, maximum and median. For the categorical epidemiological clinical variables will be calculated the frequency and percentage measures. The level of significance considered in the analyzes will be 5%. | — |
Countries
Brazil
Contacts
Public ContactWagner Fávaro
Universidade Estadual de Campinas (UNICAMP)
Outcome results
None listed