Drug Screening Using IMD in Bladder Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06204614
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

  • Muscle Invasive Bladder Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Accepted

Interventions

  • Implantable Micro-Device — DEVICE
    The implantable microdevice will release microdoses of specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against bladder cancer.
  • Methotrexate — DRUG
    Methotrexate will be placed in reservoir 1 of the implantable microdevice.
  • Carboplatin — DRUG
    Carboplatin will be placed in reservoir 2 of the implantable microdevice.
  • Avelumab — DRUG
    Avelumab will be placed in reservoir 3 of the implantable microdevice.
  • Paclitaxel — DRUG
    Paclitaxel will be placed in reservoir 4 of the implantable microdevice.
  • Vinblastine — DRUG
    Vinblastine will be placed in reservoir 5 of the implantable microdevice.
  • Gemcitabine/Cisplatin I — DRUG
    Gemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice.
  • Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab — DRUG
    (Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice.
  • Gemcitabine/Cisplatin II — DRUG
    Gemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice.
  • Cisplatin — DRUG
    Cisplatin will be placed in reservoir 9 of the implantable microdevice.
  • Nivolumab — DRUG
    Nivolumab will be placed in reservoir 10 of the implantable microdevice.
  • Pembrolizumab — DRUG
    Pembrolizumab will be placed in reservoir 11 of the implantable microdevice.
  • Gemcitabine/Carboplatin — DRUG
    Gemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice.
  • Methotrexate/Vinblastine/Doxorubicin/Cisplatin — DRUG
    (Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice.
  • Gemcitabine/Cisplatin/Nivolumab — DRUG
    (Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice.
  • Erdafitinib — DRUG
    Erdafitinib will be placed in reservoir 15 of the implantable microdevice.
  • Paclitaxel/Docetaxel/Ifosfamide — DRUG
    (Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice.
  • Gemcitabine — DRUG
    Gemcitabine will be placed in reservoir 17 of the implantable microdevice.
  • Gemcitabine/Carboplatin/Nivolumab — DRUG
    (Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice.
  • Enfortumab — DRUG
    Enfortumab will be placed in reservoir 19 of the implantable microdevice.
  • Sacituzumab — DRUG
    Sacitzumab will be placed in reservoir 20 of the implantable microdevice.

Study Details

This research study involves implanting up to 4 microdevices, each small enough to fit inside the tip of a needle, into a tumor. These devices will release microdoses (many thousands of times less than a treatment dose) of different cancer drugs into the tumor. After approximately 72 hours, the devices and small regions of surrounding tissue will be removed and studied. There will be a follow-up visit within 42 days of device removal to assess for potential safety issues or side effects.

Key Dates

Start date
Jun 14, 2024
Status verified
May 2026
Primary completion
Jul 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DRUG SCREENING USING IMD IN BLADDER CANCER
    Study participants placed in arm 1 will be implanted with the microdevice.

Primary Outcome Measure

Safety of microdevice placement and removal based on assessment of adverse events [ Time Frame: From the time of arrival to interventional radiology for microdevice placement up to 6 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

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