RecruitingNot ApplicableNCT04199026

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

20 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Sarcoma Resectable Sarcoma 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.

Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a tiny implantable microdevice that delivers small amounts of different cancer drugs directly into a tumor during surgery, allowing doctors to see which drugs are most effective for an individual patient's cancer before choosing a treatment plan. **You may be eligible if...** - You have recurrent or metastatic sarcoma (a type of cancer in bones or soft tissue) confirmed by biopsy - Surgery is already planned as part of your standard care - You are 10 years of age or older - You have a good enough general health status (ECOG 2 or below) **You may NOT be eligible if...** - You do not wish to undergo surgery, or surgery is considered too risky for you - You are under 10 years old - You are pregnant or breastfeeding - You are allergic to any of the drugs loaded in the microdevice Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoxorubicin

Given via microdevice

DRUGDoxorubicin Hydrochloride

Given via microdevice

DEVICEDrug Delivery Microdevice

Undergo percutaneous implantation of drug delivery microdevice

DRUGEverolimus

Given via microdevice

BIOLOGICALGanitumab

Given via microdevice

DRUGIfosfamide

Given via microdevice

DRUGIrinotecan

Given via microdevice

DRUGPazopanib

Given via microdevice

DRUGPolyethylene Glycol

Given via microdevice

DRUGTemozolomide

Given via microdevice

DRUGTemsirolimus

Given via microdevice

PROCEDURETherapeutic Conventional Surgery

Undergo standard of care surgery

DRUGVincristine

Given via microdevice

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04199026

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