NCT04199026 Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
| NCT ID | NCT04199026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Metastatic Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-02-25 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Joseph Ludwig, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04199026 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Metastatic Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04199026 currently recruiting?
Yes, NCT04199026 is actively recruiting participants. Contact the research team at jaludwig@mdanderson.org for enrollment information.
Where is the NCT04199026 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04199026 clinical trial?
NCT04199026 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Joseph Ludwig, MD at M.D. Anderson Cancer Center. The trial plans to enroll 20 participants.