Drug Screening Using IMD in Bladder Cancer

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to test cancer drugs for patients with muscle-invasive bladder cancer, which is a type of bladder cancer that has spread into the muscle layer of the bladder. The study will involve placing tiny devices, about the size of a needle tip, directly into the tumor. These devices will release very small amounts of different cancer medications over a period of about three days. After this time, the devices and some surrounding tissue will be removed to see how well the drugs worked. Participants will have a follow-up visit within 42 days to check for any safety concerns or side effects.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with localized bladder cancer that is planned to be treated with surgery. They should be in stable health to undergo both the device placement and the surgery. It’s also important that participants are willing to provide consent for the study, undergo some additional testing, and agree to follow specific guidelines during the study period. This trial is not yet recruiting, but it represents a promising step in finding effective treatments for bladder cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have the ability to understand and the willingness to sign a written informed consent document.
• • 2. Participants must have confirmed clinically localized bladder cancer with histology of urothelial cell carcinoma or variant histology and radiographic imaging consistent with stage T2-T3 N0 disease. Patients must be planned for cystectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.
• • 3. Participants must be 18 years of age or older. Patients must have the ability to understand and the willingness to sign a written informed consent document.
• • 4. Participants must have confirmed clinically localized bladder cancer with histology of urothelial cell carcinoma or variant histology and radiographic imaging consistent with stage T2-T3 N0 disease. Patients must be planned for cystectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.
• • 5. Participants must be 18 years of age or older. Patients must have the ability to understand and the willingness to sign a written informed consent document.
• • 6. Participants must have confirmed clinically localized bladder cancer with histology of urothelial cell carcinoma or variant histology and radiographic imaging consistent with stage T2-T3 N0 disease. Patients must be planned for cystectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.
• • 7. Participants must be 18 years of age or older.
• • 8. Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
• • 9. Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.
• • 10. Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, PT (INR) 1.5 and PTT\<1.5x control.
• • 11. Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.
• 12. The participant's case must be reviewed by the treating physician to assess the following factors:
• • Patient is clinically stable to undergo microdevice implantation and surgical procedures
• • Patient has sufficient volume of disease to allow implantation of the microdevice
• • Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery
• • 13. Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
• • 14. Patients must be agree to remain abstinent or use contraceptive measures for the duration of the study period
• Exclusion Criteria:
• • 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
• • 2. Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below in section 5.1.2.1).