Metronomic Chemotherapy for Leiomyosarcoma
(TAGGED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are currently in another investigational drug study, you must wait at least 14 days after ending that treatment before joining this trial.
Is trabectedin safe for humans?
Trabectedin has been studied in people with various types of sarcomas, including leiomyosarcoma. While it can cause side effects like blood and stomach issues, adjusting the dose can make it more tolerable. Overall, it is considered a valid and generally safe treatment option for long-term use in humans.12345
How is the drug Trabectedin unique in treating leiomyosarcoma?
Trabectedin is unique because it offers a treatment option for leiomyosarcoma that may allow for long-term use, even in patients who have not responded to other chemotherapies. It can be adjusted for tolerability and has shown effectiveness in stabilizing the disease, especially in metastatic cases.56789
What data supports the effectiveness of the drug Trabectedin for treating leiomyosarcoma?
Trabectedin has shown promise in treating leiomyosarcoma, with cases reporting prolonged disease stability and partial responses in patients who had previously not responded to other treatments. It is well-tolerated over long-term use and has been associated with stable disease in patients with metastatic leiomyosarcoma.5681011
Who Is on the Research Team?
Sant P Chawla, MD
Principal Investigator
Sarcoma Oncology Research Center, LLC
Are You a Good Fit for This Trial?
Adults with advanced leiomyosarcoma, previously treated and measurable by certain criteria, can join this trial. They must have a life expectancy of at least 3 months, be able to perform daily activities (ECOG โค 2), and have proper liver, kidney, and blood function. Participants must agree to use effective contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trabectedin, gemcitabine, and dacarbazine intravenously in 3-week cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trabectedin
Trabectedin is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarcoma Oncology Research Center, LLC
Lead Sponsor