This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.
Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is indicated as a standard of care.
10 years of age or older
Documented, signed, dated informed consent to participate in the microdevice study
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
None
Single group
Doxorubicin
DrugGiven via microdevice
Doxorubicin Hydrochloride
DrugGiven via microdevice
Drug Delivery Microdevice
DeviceUndergo percutaneous implantation of drug delivery microdevice
Everolimus
DrugGiven via microdevice
Ganitumab
Biological/VaccineGiven via microdevice
Ifosfamide
DrugGiven via microdevice
Irinotecan
DrugGiven via microdevice
Pazopanib
DrugGiven via microdevice
Polyethylene Glycol
DrugGiven via microdevice
Temozolomide
DrugGiven via microdevice
Temsirolimus
DrugGiven via microdevice
Therapeutic Conventional Surgery
Procedure/SurgeryUndergo standard of care surgery
Vincristine
DrugGiven via microdevice
Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0.
Assess the safety of microdevice placement and removal in subjects undergoing resection of sarcoma.
To assess efficacy across all individual agents or drug combinations tested using the microdevice technology.
The primary outcome measure is the number of participants that experience a grade 3 or 4 adverse event, as defined by CTCAE 5.0. A second primary outcome measure of device technical feasibility measures the number of devices that successfully generate high-quality data from each of at least 50% of the patients enrolled. A successful device is one that generated high-quality data from at least 40% of the drugs in the device by IHC and/or other methodologies
Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir.
The degree of cell apoptosis and cell proliferation observed in the adjacent tumor tissues will be compared for the placebo control (i.e. PEG) to gauge the antineoplastic effect elicited by each of the drug micro-doses released by the respective microdevice reservoirs.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
