Actively Recruiting

Phase Not Applicable
Age: 10Years +
All Genders
NCT04199026

Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma

Led by M.D. Anderson Cancer Center · Updated on 2026-02-19

20

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma

Who Can Participate

Age: 10Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients who do not wish to undergo surgical resection or are high-risk or not candidates for surgery
  • Younger than 10 years old
  • Women of childbearing potential without a negative pregnancy test or who are lactating
  • Allergies or prior adverse reactions to any drugs loaded in the microdevice

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

J

Joseph A Ludwig, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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