The study is a pilot study in the feasibility of a diagnostic technique. There is no current data on detection of cisplatin in cancer cells derived from human urine. This study will generate preliminary data so that future studies may be done with more definitive end points in mind.
The aim of this study is to determine the feasibility of using a novel mass spectrometry
instrument to measure the intracellular concentration of chemotherapeutic drug within an
active tumor cell. If successful, this technique could be applied to dosage streamlining in
patients and customization of dosage based on individual tumor characteristics. It also opens
the door to research on novel chemotherapy agents or agents not typically used in a specific
malignancy to determine if therapeutic levels can be obtained in tumor cells.
Personalized chemotherapy is an evolving field with the underlying goal being minimization of
side effects of treatment while maximizing net patient benefit for therapy. A key difficulty
in personalized chemotherapy is that the determination of therapeutic benefit comes well
after the administration of treatment has been completed. For most forms of chemotherapy
there does not exist a laboratory study that can determine the concentration of therapeutic
agent within the tumor itself and as such, real time dose adjustments are based only on
toxicity, not on tumor penetrance.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||July 1, 2017||Observational|
Primary Outcome 1 - Measure: Measurement of the intracellular concentration
Primary Outcome 1 - Time Frame: 4 years
1. Patients must have a diagnosis of bladder cancer
2. Patients must be undergoing their first cycle of cisplatin based chemotherapy due to
metastatic disease or as pre-operative treatment before cystectomy
<br/> 3. Patients with a diagnosis of bladder cancer who will not be undergoing chemotherapy
4. Patients must have demonstrated positive urinary cytology prior to inclusion in the
1. Patients who do not have bladder cancer.
Minimum Age: 30 Years
Maximum Age: 99 Years
Healthy Volunteers: No
Name: Jonathan Heinlen, M.D.
Role: Principal Investigator
Affiliation: University of Oklahoma HSC, Department of Urology