Study on Lurbinectedin and Doxorubicin for Treating Leiomyosarcoma
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT05099666
This clinical trial is testing a combination of two drugs, lurbinectedin and doxorubicin, to see if they are safe and effective in treating leiomyosarcoma, a type of soft tissue cancer. The study will compare the combination treatment to using lurbinectedin alone.
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Program Overview
The study aims to find out if combining lurbinectedin with doxorubicin is safe and effective for people with leiomyosarcoma, a type of soft tissue cancer. The trial has two parts: the first part checks how well people tolerate the combination of the two drugs, and the second part compares the effectiveness of the combination treatment against lurbinectedin alone.
Description
This clinical trial is in two phases: Phase 1b and Phase 2.
In Phase 1b, researchers will determine the safest dose of lurbinectedin when used with doxorubicin. This phase will help decide the best dose to use in the next phase.
In Phase 2, participants with advanced leiomyosarcoma will be randomly assigned to receive either the combination of lurbinectedin and doxorubicin or just doxorubicin alone. This phase will help determine which treatment is more effective.
Lurbinectedin is a drug that binds to DNA and may cause cancer cells to die. It is approved for treating small cell lung cancer but not yet for leiomyosarcoma. Doxorubicin is a chemotherapy drug that is already approved for treating soft tissue sarcoma, including leiomyosarcoma.
The study is open-label, meaning both the researchers and participants know which treatment is being given. Participants will be closely monitored for side effects and how well the cancer responds to the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have advanced or metastatic soft tissue sarcoma for Phase 1b, or advanced or metastatic leiomyosarcoma for Phase 2, with no other treatment options available.
- Must have measurable cancer according to specific medical criteria.
- Must be 18 years or older.
- Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
- Must have adequate organ and bone marrow function, as shown by specific blood tests.
- Must not have active hepatitis B or C infections, or must have these infections under control.
- Must have a heart function of at least 50% as shown by specific heart tests.
- Women and men must agree to use effective birth control during the study and for six months after.
- Must be able to understand and sign a consent form.
- Must have a sample of their tumor available for analysis, unless approved otherwise.
- May have other cancers if they do not interfere with the study treatment.
Exclusion Criteria
- Cannot have had previous treatment with certain chemotherapy drugs, including doxorubicin, or more than two prior chemotherapy treatments for Phase 1b, or more than one for Phase 2.
- Cannot have had certain types of radiation or surgery recently.
- Cannot have active brain disease, unless previously treated and stable.
- Cannot have allergies to similar drugs.
- Cannot be taking certain medications that interact with the study drugs.
- Cannot have uncontrolled illnesses or infections.
- Cannot have a history of lung diseases like pneumonitis or fibrosis.
- Cannot be pregnant or breastfeeding, and women must have a negative pregnancy test before starting the study.
- Cannot have a weakened immune system, including HIV infection.
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