Phase II Study of Nab-Sirolimus for Patients with Worsening or Symptomatic Epithelioid Hemangioendothelioma
Sponsor: Sarcoma Alliance for Research through Collaboration
ClinicalTrials ID:NCT07104331
This clinical trial is testing the drug nab-Sirolimus to see if it can help patients with epithelioid hemangioendothelioma (EHE) that is getting worse or causing symptoms. The study involves giving the drug through an IV on specific days of a 21-day cycle.
Patient Parameters
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Program Overview
This study is designed to test the effectiveness of nab-Sirolimus in patients with epithelioid hemangioendothelioma (EHE) that is either worsening or causing symptoms. The drug is given through an IV on Days 1 and 8 of each 21-day cycle. The main goal is to see how well the drug can shrink tumors in these patients.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of EHE that is worsening or causing symptoms and cannot be treated with surgery.
- Must have at least one tumor that can be measured accurately by scans or exams.
- Must be 18 years or older.
- Must be in relatively good health with an ECOG performance status of 0 to 2.
- Must have adequate blood and organ function, including:
- Platelet count above 75,000
- Neutrophil count above 1,500
- Hemoglobin level above 9 g/dL
- Creatinine level within normal limits or creatinine clearance above 30
- Bilirubin level less than twice the normal limit
- Liver enzymes (AST/ALT) less than three times the normal limit
- Must have recovered from any side effects of previous treatments to a mild level, except for hair loss or nerve damage.
- Women and men must agree to use effective birth control during the study and for a period after the study.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
- Must be able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Cannot have an active, uncontrolled infection or severe heart failure.
- Cannot have active hepatitis B or C infections unless they are controlled.
- Cannot have had major surgery within 28 days before starting the study.
- Cannot have active brain disease or severe past brain-related side effects from drugs.
- Cannot have psychiatric or substance abuse issues that would interfere with the study.
- Cannot have had a heart attack within the last 12 months.
- Cannot have other active cancers or be taking other cancer treatments, except for certain hormone therapies.
- Pregnant women cannot participate due to potential risks to the baby.
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