Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

31mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress34%

Feb 2025Dec 2028

First Submitted

Initial submission to the registry

September 13, 2019

Completed

3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed

5.2 years until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

September 13, 2019

Last Update Submit

February 17, 2026

Conditions

Metastatic Sarcoma Recurrent Sarcoma Resectable Sarcoma

Outcome Measures

Primary Outcomes (2)

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.
Up to 1 year
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
Up to 1 year

Secondary Outcomes (1)

Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir.
Up to 1 year

Study Arms (1)

Device Feasibility (microdevice, surgery)

EXPERIMENTAL

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.

Drug: DoxorubicinDrug: Doxorubicin HydrochlorideDevice: Drug Delivery MicrodeviceDrug: EverolimusBiological: GanitumabDrug: IfosfamideDrug: IrinotecanDrug: PazopanibDrug: Polyethylene GlycolDrug: TemozolomideDrug: TemsirolimusProcedure: Therapeutic Conventional SurgeryDrug: Vincristine

Interventions

EverolimusDRUG

Given via microdevice

Also known as: 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress