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New treatment option for Metastatic Sarcoma
Official title Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
ClinicalTrials.gov ID: NCT04199026
What this study is testing
What is Doxorubicin?
Doxorubicin is an investigational medicine, being studied as a potential treatment for metastatic sarcoma.
Also referred to as Adriablastin, Hydroxydaunomycin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older
You may be able to join if
- 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:
See the full 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:
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.