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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Daunorubicin; Doxorubicin; Everolimus; Ifosfamide; Irinotecan; Isophosphamide mustard; Liposomal doxorubicin; Sirolimus; Temozolomide; Vincristine

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

• ECOG performance status of 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.