What side effects are associated with this type of intervention?

Common treatments for Kaposi's Sarcoma that inhibit tumor cell proliferation and angiogenesis, such as sEphB4-HSA, may include agents like bevacizumab and other antiangiogenic drugs. Known side effects of these treatments can include fatigue, hypertension, proteinuria, bleeding complications, and gastrointestinal perforations. Additionally, patients may experience infusion-related reactions such as chills, fever, and nausea. It is important to monitor for these side effects and manage them appropriately in clinical settings.

What prior FDA approvals exist?

FDA-approved treatments for Kaposi's Sarcoma include liposomal doxorubicin (Doxil) and paclitaxel, which target tumor cell proliferation. Additionally, bevacizumab, an angiogenesis inhibitor, has been used off-label for Kaposi's Sarcoma. These treatments aim to reduce tumor growth and the formation of new blood vessels, similar to the mechanism of sEphB4-HSA being studied.

What other types of research exist?

Promising, novel alternatives to sEphB4-HSA for Kaposi's Sarcoma patients include sirolimus and sorafenib. Sirolimus has shown rapid improvement in related vascular tumors, and sorafenib is a multikinase inhibitor that targets angiogenesis and tumor proliferation pathways.

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Protein-based Therapy

sEphB4-HSA for Kaposi's Sarcoma

Phase 2

Recruiting

Led By Carl Millner, M.D.

Research Sponsored by Vasgene Therapeutics, Inc

Eligibility Criteria Checklist

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

Must have

Creatinine within normal institutional limit for the reference lab OR creatinine clearance ≥ 60 mL/min/1.73 m2 as calculated by Cockcroft-Gault formula for participants with creatinine levels above institutional normal

ECOG performance status ≤ 2 or Karnofsky performance score (KPS) ≥ 50%

Must not have

Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events

Participants for whom front-line cytotoxic therapy is indicated (i.e. symptomatic visceral or pulmonary Kaposi Sarcoma or symptomatic Kaposi Sarcoma impairing functional status)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 4 weeks until study completion (average 6 months).

Awards & highlights

Summary

This trial is testing a drug called sEphB4-HSA to see if it can reduce the number or size of cancerous lesions in people with Kaposi sarcoma. The drug works by stopping cancer cells from growing and cutting off their nutrient supply.

Who is the study for?

Adults with biopsy-proven Kaposi Sarcoma (skin or visceral) can join this trial. They must be over 18, have a life expectancy of more than 3 months, and be able to follow the study plan. People with HIV are eligible if they've been on stable antiretroviral therapy for at least 12 weeks. Women who can get pregnant and men must use birth control during the study.

What is being tested?

The trial is testing sEphB4-HSA, which may stop tumor cells from growing by blocking substances that help tumors get nutrients through blood vessels. The goal is to see if it reduces the number or size of Kaposi sarcoma lesions.

What are the potential side effects?

Potential side effects aren't specified here but based on similar treatments, one might expect issues like injection site reactions, fatigue, nausea, or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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

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I can take care of myself but might not be able to do active work.

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I have Kaposi's sarcoma confirmed by a skin biopsy.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have brain metastases.

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I need immediate strong therapy for my Kaposi Sarcoma because it's causing symptoms or affecting my daily activities.

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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 serious bleeding or needed a blood transfusion in the last 6 months.

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I have had a stroke or mini-stroke in the last year.

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I do not have serious heart conditions like severe heart failure, unstable chest pain, or irregular heartbeats.

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I am currently receiving treatment for another cancer.

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I am not pregnant, lactating, or breastfeeding.

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I am able to understand and give informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 weeks until study completion (average 6 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 4 weeks until study completion (average 6 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks until study completion (average 6 months). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS.

Secondary study objectives

Changes in the VEGF-Notch-EphrinB2 angiogenic pathway

Cmax levels of recombinant sEphB4-HSA fusion protein

Effects of sEphB4-HSA on human immunodeficiency virus (HIV) plasma viral loads in participants with HIV

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Trial Design

1Treatment groups

Experimental Treatment

Group I: Study DrugExperimental Treatment1 Intervention

All study participants will receive sEphB4-HSA through a needle in a vein in their arm for an hour in an outpatient clinic. All study participants will receive two doses of study drug on Days 1 and 15 of each 4 week cycle.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Kaposi's Sarcoma (KS) treatments often target tumor cell proliferation and angiogenesis, which are critical for tumor growth and survival. sEphB4-HSA, for example, works by preventing tumor cells from multiplying and blocking the growth of blood vessels that supply nutrients to the tumor. This dual action is crucial for KS patients because it directly inhibits the tumor's ability to grow and spread, potentially reducing the number and size of lesions. By targeting these pathways, treatments like sEphB4-HSA can effectively manage KS and improve patient outcomes.

A Screen for Extracellular Signal-Regulated Kinase-Primed Glycogen Synthase Kinase 3 Substrates Identifies the p53 Inhibitor iASPP.