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

RecruitingNAAges 10 Years - anyAllM.D. Anderson Cancer Center
NCT04199026 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Doxorubicin
  • Doxorubicin Hydrochloride
  • Drug Delivery Microdevice
  • Everolimus
  • Ganitumab
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Where

1 site
M D Anderson Cancer Center
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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