Recruiting

Implantable Microdevice

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04199026

Conditions

Metastatic Sarcoma

Recurrent Sarcoma

Resectable Sarcoma

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

Doxorubicin

Doxorubicin Hydrochloride

Drug Delivery Microdevice

Everolimus

Ganitumab

Study Details

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.

Conditions

Metastatic Sarcoma

Recurrent Sarcoma

Resectable Sarcoma

Study ID

NCT04199026

Start date

Feb 25, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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 adverse drug reactions to any of the drugs loaded within the microdevice.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Device Feasibility (microdevice, surgery)

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.

Interventions

Doxorubicin

Given via microdevice

Doxorubicin Hydrochloride

Given via microdevice

Drug Delivery Microdevice

Undergo percutaneous implantation of drug delivery microdevice

Everolimus

Given via microdevice

Ganitumab

Given via microdevice

Ifosfamide

Given via microdevice

Irinotecan

Given via microdevice

Pazopanib

Given via microdevice

Polyethylene Glycol

Given via microdevice

Temozolomide

Given via microdevice

Temsirolimus

Given via microdevice

Therapeutic Conventional Surgery

Undergo standard of care surgery

Vincristine

Given via microdevice

Primary outcome measure

  • Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0. [ Time Frame: Up to 1 year ]
  • To assess efficacy across all individual agents or drug combinations tested using the microdevice technology. [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Joseph A Ludwig, MD

713-792-3626jaludwig@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Joseph A. Ludwig

713-792-3626jaludwig@mdanderson.org

Principal Investigator:

Joseph A. Ludwig

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-11.