NCT04199026

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. EXPLORATORY OBJECTIVES: I. Evaluate the microdevice performance for its capacity to predict Response Evaluation Criteria in Solid Tumors (RECIST) response in the subset of patients that receive systemic chemotherapies as part of their standard-of-care or clinical trial treatments. II. Determine genomic, transcriptomic, and proteomic predictive biomarkers from resected specimens that correlate with local (i.e. microdevice-based) and systemic drug response. III. Determine, at a single-cell level, proteomic traits associated with chemosensitivity versus (vs.) resistance using mathematical notions of network robustness and fragility. OUTLINE: Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery. Patients receive doxorubicin hydrochloride, ifosfamide, vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab, and temsirolimus via the microdevice in the absence of unacceptable toxicity. At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed. Conditions Conditions: Metastatic Sarcoma Recurrent Sarcoma

Conditions

• Metastatic Sarcoma
• Recurrent Sarcoma
• Resectable Sarcoma

Interventions

Type	Name	Description
DRUG	Doxorubicin	Given via microdevice
DRUG	Doxorubicin Hydrochloride	Given via microdevice
DEVICE	Drug Delivery Microdevice	Undergo percutaneous implantation of drug delivery microdevice
DRUG	Everolimus	Given via microdevice
BIOLOGICAL	Ganitumab	Given via microdevice
DRUG	Ifosfamide	Given via microdevice
DRUG	Irinotecan	Given via microdevice
DRUG	Pazopanib	Given via microdevice
DRUG	Polyethylene Glycol	Given via microdevice
DRUG	Temozolomide	Given via microdevice
DRUG	Temsirolimus	Given via microdevice
PROCEDURE	Therapeutic Conventional Surgery	Undergo standard of care surgery
DRUG	Vincristine	Given via microdevice

Timeline

• Start date: 2025-02-25
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2019-12-13
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study