Drug Delivery Microdevice for Sarcoma
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of this drug for treating sarcoma?
Research shows that drug delivery systems, including microdevices, have significantly improved cancer treatments by allowing controlled and localized delivery of drugs, which can enhance their effectiveness and reduce side effects. Additionally, studies indicate that delivering cancer drugs directly into tumors can help determine their effectiveness, potentially improving patient outcomes.12345
Is the Drug Delivery Microdevice for Sarcoma generally safe for humans?
How does the Drug Delivery Microdevice treatment for sarcoma differ from other treatments?
The Drug Delivery Microdevice for sarcoma is unique because it allows for localized delivery of drugs directly to the tumor site, minimizing systemic side effects and improving drug effectiveness. This approach contrasts with traditional systemic chemotherapy, which can have widespread side effects and limited tumor penetration.511121314
Research Team
Joseph A. Ludwig
Principal Investigator
The University of Texas MD Anderson Cancer Center
Eligibility Criteria
This trial is for people aged 10 or older with sarcoma that has spread or returned, and who need surgery as part of their treatment. They must be able to perform daily activities (ECOG <=2) and consent to participate. It's not for those under 10, pregnant or breastfeeding women, patients refusing surgery, or with allergies to drugs in the microdevice.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Microdevice Implantation
Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery
Surgery and Microdevice Removal
At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Doxorubicin
- Doxorubicin Hydrochloride
- Drug Delivery Microdevice
- Everolimus
- Ganitumab
- Ifosfamide
- Irinotecan
- Pazopanib
- Polyethylene Glycol
- Temozolomide
- Temsirolimus
- Vincristine
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator