Predicting BCG Response
ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorCedars-Sinai Medical Center
About this trial
To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.
Eligibility criteria
Qualifiers
Age 18 years or older
Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder diagnosed within 90 days prior to scheduled BCG
Patients must have had all grossly visible papillary tumors removed within 30 days prior to scheduled BCG or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to scheduled BCG
Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (CT scan or MRI scan) within 90 days prior to scheduled BCG
Disqualifiers
Previous intravesical BCG therapy
Patients must not be taking oral glucocorticoids at the time of registration.
Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.
Patients must not have known history of tuberculosis.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Cedars-Sinai Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Nonagen Bioscience Corporation
Collaborator
University of California, San Francisco
Collaborator
Kyoto University
Collaborator
University of California, Los Angeles
Collaborator
Source ClinicalTrials.gov