Brigham and Women's Hospital
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.
This is a phase I pilot study of microdevice implantation and retrieval in patients with primary bladder cancer. The microdevice is 5x1mm and can be deployed using a biopsy needle placed percutaneously using imaging guidance. The purpose of the microdevice is to measure local intratumor response to antitumor medications in patients with primary bladder cancer. The microdevice contains multiple, separate reservoirs that are each loaded with a specific drug or drug combination. Candidate patients will first be evaluated based on a CT or MRI, obtained as part of clinical care, and a physician wh…
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 writt…
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 will be placed in reservoir 1 of the implantable microdevice.
Carboplatin will be placed in reservoir 2 of the implantable microdevice.
Avelumab will be placed in reservoir 3 of the implantable microdevice.
Paclitaxel will be placed in reservoir 4 of the implantable microdevice.
Vinblastine will be placed in reservoir 5 of the implantable microdevice.
Gemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice.
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice.
Gemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice.
Cisplatin will be placed in reservoir 9 of the implantable microdevice.
Nivolumab will be placed in reservoir 10 of the implantable microdevice.
Pembrolizumab will be placed in reservoir 11 of the implantable microdevice.
Gemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice.
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice.
(Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice.
Erdafitinib will be placed in reservoir 15 of the implantable microdevice.
(Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice.
Gemcitabine will be placed in reservoir 17 of the implantable microdevice.
(Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice.
Enfortumab will be placed in reservoir 19 of the implantable microdevice.
Sacitzumab will be placed in reservoir 20 of the implantable microdevice.
Arctuva estimate
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