This phase II trial studies bacillus Calmette-Guérin (BCG) solution in treating patients with bladder cancer that has spread beyond the layer of tissue in which it developed and is growing into surrounding, healthy tissues (invasive). Biological therapies, such as BCG solution, may stimulate the immune system in different ways and stop tumor cells from growing. Infusing BCG solution directly into the bladder may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02365207.
PRIMARY OBJECTIVES:
I. To determine the ability of intravesical BCG (BCG solution) immunotherapy to enhance tumor-specific immunity as measured by autologous T cells proliferation following co-culture with autologous monocyte-derived dendritic cells pulsed with autologous tumor lysate.
SECONDARY OBJECTIVES:
I. To determine the immune effects of BCG in the tumor microenvironment and tumor-draining lymph nodes.
II. To determine the extent to which BCG is processed and presented by tumors cells and/or antigen-presenting cells.
III. To determine the ability of BCG to elicit tumor necrosis/apoptosis in invasive disease.
IV. To determine the pathologic stage of disease following BCG treatment.
V. To determine if immune changes elicited by BCG in patients with bladder cancer will provide an opportunity for benefit from mammalian target of rapamycin (mTOR) inhibition in tumor milieu.
OUTLINE:
Patients receive an instillation of BCG solution intravesically which is then held in the bladder for 2 hours. Treatment repeats weekly for 3-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
After completion of study treatment, patients are followed up at approximately within 90 days.
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorRobert Scott Svatek
