Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas
M.D. Anderson Cancer Center
20 participants
Feb 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is indicated as a standard of care.
- 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
Exclusion Criteria4
- Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection
- Age \< 10 years old
- Women of childbearing potential without a negative pregnancy test; or women who are lactating
- Allergies or prior adverse drug reactions to any of the drugs loaded within the microdevice.
Interventions
Given via microdevice
Given via microdevice
Undergo percutaneous implantation of drug delivery microdevice
Given via microdevice
Given via microdevice
Given via microdevice
Given via microdevice
Given via microdevice
Given via microdevice
Given via microdevice
Given via microdevice
Undergo standard of care surgery
Given via microdevice
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04199026