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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorM.D. Anderson Cancer Center

About this trial

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

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Doxorubicin
  • Doxorubicin Hydrochloride
  • Drug Delivery Microdevice
  • Everolimus
  • Ganitumab
  • Ifosfamide
  • Irinotecan
  • Pazopanib
  • Polyethylene Glycol
  • Temozolomide
  • Temsirolimus
  • Therapeutic Conventional Surgery
  • Vincristine

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator