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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04199026
Status
Recruiting
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Conditions

  • Metastatic Sarcoma
  • Recurrent Sarcoma
  • Resectable Sarcoma

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doxorubicin — DRUG
    Given via microdevice
  • Doxorubicin Hydrochloride — DRUG
    Given via microdevice
  • Drug Delivery Microdevice — DEVICE
    Undergo percutaneous implantation of drug delivery microdevice
  • Everolimus — DRUG
    Given via microdevice
  • Ganitumab — BIOLOGICAL
    Given via microdevice
  • Ifosfamide — DRUG
    Given via microdevice
  • Irinotecan — DRUG
    Given via microdevice
  • Pazopanib — DRUG
    Given via microdevice
  • Polyethylene Glycol — DRUG
    Given via microdevice
  • Temozolomide — DRUG
    Given via microdevice
  • Temsirolimus — DRUG
    Given via microdevice
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo standard of care surgery
  • Vincristine — DRUG
    Given via microdevice

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Device Feasibility (microdevice, surgery)
    Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery. Patients receive doxorubicin hydrochloride, ifosfamide, vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab, and temsirolimus via the microdevice in the absence of unacceptable toxicity. At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed.

Primary Outcome Measure

Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0. [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Joseph A. Ludwig
[email protected]
713-792-3626
Joseph A. Ludwig (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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