L19TNF + Doxorubicin for Metastatic Leiomyosarcoma
(FIBROSARC US Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require chronic corticosteroids, other immunosuppressants, or anticoagulants, and you should not use other anti-cancer treatments during the study.
Is the combination of L19TNF and Doxorubicin safe for humans?
Doxorubicin is known to cause heart-related side effects, such as cardiotoxicity (damage to the heart muscle), which can be severe. Liposomal formulations of Doxorubicin may have lower risks of these side effects compared to conventional forms. There is no specific safety data available for L19TNF in combination with Doxorubicin.12345
What makes the drug L19TNF + Doxorubicin unique for treating metastatic leiomyosarcoma?
L19TNF + Doxorubicin is unique because it combines Doxorubicin, a standard first-line treatment for metastatic leiomyosarcoma, with L19TNF, which may enhance the drug's effectiveness by targeting tumor cells more precisely. This combination aims to improve outcomes by potentially increasing the drug's ability to attack cancer cells while minimizing side effects.678910
What data supports the effectiveness of the drug L19TNF + Doxorubicin for treating metastatic leiomyosarcoma?
Doxorubicin is commonly used as a first-line treatment for leiomyosarcoma, but it is often not effective on its own. However, in other studies, doxorubicin has shown some activity against different types of cancer, such as malignant mesothelioma, when used in a modified form. This suggests that doxorubicin might have potential when combined with other treatments like L19TNF.68111213
Who Is on the Research Team?
Scott Okuno, MD
Principal Investigator
Mayo Clinic, Rochester, MN
Are You a Good Fit for This Trial?
This trial is for adults and fully grown minors (16+) with stage IV high-grade leiomyosarcoma, a type of soft tissue sarcoma. Participants must have a life expectancy over 3 months, be HIV/HBV/HCV negative, not pregnant or breastfeeding, and willing to use effective contraception. They should not have had previous anthracycline chemo, certain heart conditions or severe diseases that could affect study participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive doxorubicin or L19TNF plus doxorubicin in 21-day cycles
Maintenance
Participants continue treatment with monitoring every 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Doxorubicin
- L19TNF
Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Philogen S.p.A.
Lead Sponsor