Study on sEphB4-HSA for Treating Kaposi Sarcoma

Sponsor: Vasgene Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03993106

Provider View

This clinical trial is testing a new treatment called sEphB4-HSA to see if it can reduce the number or size of Kaposi sarcoma lesions. The treatment works by stopping tumor cells from growing and blocking substances that help tumors get nutrients.

Patient Parameters

Program Overview

The study aims to find out if sEphB4-HSA can decrease the number or size of Kaposi sarcoma lesions. sEphB4-HSA is given through an IV infusion, and each treatment cycle lasts 28 days. Participants will receive the treatment on Days 1 and 15 of each cycle. They can continue the treatment as long as their condition is stable or improving. Participants may stop treatment if their disease progresses, they experience severe side effects, or if they choose to withdraw from the study.

Description

Participants in this study will receive sEphB4-HSA through an IV infusion. Each treatment cycle is 28 days long, with doses given on Days 1 and 15. Participants can continue receiving the treatment as long as their Kaposi sarcoma is stable or improving. Reasons for stopping treatment include disease progression, severe side effects, delays in treatment, withdrawal of consent, or study termination. Participants must follow the study requirements, including taking the medication as directed and attending all appointments and tests.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed Kaposi sarcoma affecting the skin, with or without internal involvement.
  • Participants can be new to treatment, or have not responded to or tolerated previous treatments.
  • If HIV-positive, any CD4 count is allowed.
  • Must have a performance status that allows for daily activities with some limitations.
  • Life expectancy of more than 3 months.
  • Must meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Must provide documentation of HIV status.
  • Must not have shown improvement in Kaposi sarcoma in the 3 months before joining the study, unless there is evidence of progression in the 4 weeks before joining.
  • Must be able to comply with the study protocol.

Exclusion Criteria

  • Unable to understand or provide consent.
  • Currently receiving other investigational treatments.
  • Recent treatment for Kaposi sarcoma within 4-6 weeks before the study.
  • Known brain metastases.
  • Allergic reactions to similar treatments.
  • Active infections requiring treatment, except for oral thrush or genital herpes.
  • Need for immediate cytotoxic therapy for Kaposi sarcoma.
  • Other cancers requiring cytotoxic therapy.
  • Recent history of another primary cancer, except for certain skin or cervical cancers.
  • Use of steroids, except for specific conditions.
  • Pregnant or breastfeeding women.
  • Recent major health events like heart attacks or strokes.
  • High blood pressure not controlled by medication.
  • Recent major bleeding events.
  • Use of certain blood thinners.
  • Serious heart conditions.
  • Physical or mental health issues that could affect study participation.

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