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

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

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Joseph Ludwig, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-25

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Device

Yes

Countries

• United States

Study Locations