Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas
M.D. Anderson Cancer Center
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.
Description
PRIMARY OBJECTIVES: I. Assess the safety of drug delivery microdevice (microdevice) placement and removal in subjects undergoing resection of sarcoma. II. Determine the technical feasibility of microdevice placement and removal with intact surrounding tissue in subjects undergoing resection of a sarcoma. SECONDARY OBJECTIVE: I. Use the intratumoral cellular response to evaluate individual agents and/or drug combinations released from the microdevice reservoirs to assess the relative drug efficacy across all individual agents or drug combinations tested using the microdevice technology. EX…
Eligibility
- Age range
- 10+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion: * 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 Exclusion: * 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 adver…
Interventions
- DrugDoxorubicin
Given via microdevice
- DrugDoxorubicin Hydrochloride
Given via microdevice
- DeviceDrug Delivery Microdevice
Undergo percutaneous implantation of drug delivery microdevice
- DrugEverolimus
Given via microdevice
- BiologicalGanitumab
Given via microdevice
- DrugIfosfamide
Given via microdevice
- DrugIrinotecan
Given via microdevice
Location
- M D Anderson Cancer CenterHouston, Texas