Study on Treatment for Metastatic Soft Tissue Sarcoma (FIBROSARC USA)
Sponsor: Philogen S.p.A.
ClinicalTrials ID:NCT03420014
This clinical trial is testing a new treatment combination for patients with metastatic leiomyosarcoma, a type of soft tissue cancer. The study compares the effectiveness of a new drug, L19TNF, combined with doxorubicin, against doxorubicin alone.
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Program Overview
The study aims to find out if adding L19TNF to the standard chemotherapy drug doxorubicin can improve treatment outcomes for patients with metastatic leiomyosarcoma, a type of soft tissue sarcoma. Participants will be randomly assigned to receive either doxorubicin alone or the combination of L19TNF and doxorubicin. The main goal is to see if the combination treatment can help patients live longer without the cancer getting worse. The effectiveness of the treatment will be checked every 6 weeks during the therapy and every 12 weeks after that.
Description
In this study, 122 patients will be randomly divided into two groups. One group will receive the standard treatment with doxorubicin, while the other group will receive a combination of doxorubicin and a new drug called L19TNF. The main goal is to see if the combination treatment can help patients with metastatic leiomyosarcoma live longer without their cancer getting worse. The study will monitor the cancer's response to the treatment every 6 weeks during the therapy and every 12 weeks after the treatment ends.
Eligibility Criteria
Inclusion Criteria
- Must be 16 years or older. Patients under 18 must be fully grown.
- Have stage IV metastatic high-grade leiomyosarcoma that cannot be treated with surgery or radiotherapy.
- Have at least one measurable tumor that has not been treated with radiation.
- Expected to live at least 3 more months.
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Test negative for HIV, hepatitis B, and hepatitis C.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for six months after.
- Men must agree to use two forms of birth control during the study.
- Must sign an informed consent form and be willing to follow the study procedures.
Exclusion Criteria
- Have had previous treatment for metastatic soft tissue sarcoma, except surgery and radiation.
- Have a primary tumor in the limbs with a single removable distant metastasis.
- Eligible for pre-surgery treatment.
- Have had chemotherapy with anthracyclines before.
- Have had radiation therapy within 4 weeks before starting the study.
- Have allergies to TNFα, anthracyclines, or similar drugs.
- Have low blood cell counts or poor kidney or liver function.
- Have severe health conditions that could interfere with the study.
- Have had heart problems or certain heart conditions.
- Have uncontrolled high blood pressure or severe diabetes-related eye disease.
- Have had major surgery within 4 weeks before starting the study.
- Are pregnant or breastfeeding.
- Need long-term steroid or immunosuppressant treatment.
- Have active infections or other serious health issues.
- Have active or latent tuberculosis.
- Have other cancers unless disease-free for at least 2 years.
- Have serious wounds or fractures.
- Are allergic to the study medication.
- Are taking blood thinners or other cancer treatments.
- Have had a live vaccine within 4 weeks before starting the study.
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