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Virus Therapy

sEphB4-HSA for Kaposi Sarcoma

Phase 2

Waitlist Available

Led By Ida Wong-Sefidan

Research Sponsored by AIDS Malignancy Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have biopsy-proven KS involving skin with or without visceral involvement

Documentation of HIV status; if participant is HIV positive, HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection

Must not have

Participants with diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months, or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the participant at undue risk for treatment related complications

Concurrent, acute, active infection, or treatment for infection, other than oral thrush or genital herpes, within 14 days of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks (after 2 courses) and up to 12 months (end of follow-up)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a protein that may help to treat Kaposi sarcoma by blocking the growth of blood vessels that provide blood to the cancer, and by preventing cancer cells from growing.

Who is the study for?

This trial is for individuals with Kaposi Sarcoma, which may include those who haven't been treated before or those who didn't respond to or couldn't tolerate previous treatments. HIV-positive participants are welcome if they're on stable antiretroviral therapy. Participants need a life expectancy over 3 months and must have skin lesions suitable for biopsy. They should not be pregnant and must agree to use effective birth control methods.

What is being tested?

The study is testing the effects of recombinant EphB4-HSA fusion protein on Kaposi Sarcoma. This treatment aims to block blood vessel growth that feeds cancer cells and prevent the cancer cells from growing further.

What are the potential side effects?

While specific side effects of recombinant EphB4-HSA in this context aren't detailed, similar treatments can cause reactions at the infusion site, fatigue, changes in blood pressure, potential bleeding issues, and could affect organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Kaposi's sarcoma confirmed by a biopsy, affecting my skin and possibly other organs.

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I have documentation of my HIV status, positive or negative.

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I have skin lesions that can be biopsied and others that haven't improved in a month.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I am mostly self-sufficient and can carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe diabetes, COPD requiring recent hospitalization, or conditions that make treatment risky for me.

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I have not had a serious infection or been treated for one in the last 14 days.

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I have severe heart failure symptoms.

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I have not had a major heart attack or stroke in the last 6 months.

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I haven't had any serious bleeding or needed a blood transfusion in the last 6 months.

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I do not have brain metastases.

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I have early-stage cervical cancer.

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I have an irregular heartbeat.

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I am not pregnant, lactating, or breastfeeding.

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I am HIV positive and choose not to take antiretroviral therapy.

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I need immediate strong treatment for my Kaposi's sarcoma symptoms.

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I have unstable chest pain.

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I am able to understand and give informed consent.

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My condition is early-stage anal cancer.

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I am currently receiving treatment for another cancer.

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My blood pressure is high (>140/90) despite taking medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks (after 2 courses) and up to 12 months (end of follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks (after 2 courses) and up to 12 months (end of follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks (after 2 courses) and up to 12 months (end of follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants experiencing clinical response

Proportion of participants experiencing unacceptable toxicity

Secondary study objectives

Pharmacodynamic parameters of recombinant EphB4-HSA fusion protein

Trough levels of recombinant EphB4-HSA fusion protein

Other study objectives

Overall quality of life, assessed using the KS Functional Assessment of HIV questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (recombinant EphB4-HSA fusion protein)Experimental Treatment4 Interventions

Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1 and 15. Patients with disease progression after 2 or more courses who have not experienced toxicity may receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of further disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quality-of-Life Assessment

2017

Completed Phase 3

~4950

0 / 21Eligibility criteria met