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Search / Trial NCT04199026

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

Launched by M.D. ANDERSON CANCER CENTER · Dec 12, 2019

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with metastatic or recurrent sarcoma, which is a type of cancer that affects the connective tissues. Researchers are testing a small device, about the size of a grain of rice, that can be implanted directly into the tumor. This device is loaded with tiny amounts of 10 different drugs, called microdoses, which are designed to target the tumor more precisely. The main goal is to see how these drugs affect the tumor tissue and to better understand their side effects.

To participate in this study, candidates need to be at least 10 years old and have a confirmed diagnosis of recurrent or metastatic sarcoma that requires surgery. They also need to be in fairly good health, as indicated by a performance status rating. Participants can expect to have the microdevice implanted and then removed later, while being monitored for any side effects. It's important to know that women who could become pregnant must have a negative pregnancy test before joining the trial. This study is currently recruiting, and it offers a potential new way to treat sarcoma while helping researchers learn more about this cancer.

Gender

ALL

Eligibility criteria

  • 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.

About M.D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Joseph Ludwig, MD

Principal Investigator

The University of Texas MD Anderson Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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