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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks until study completion (average 6 months).
Awards & highlights
Study Summary
This trialstudies if sEphB4-HSA can reduce the growth of Kaposi sarcoma by blocking tumor cell growth and stopping blood vessels from supplying nutrients.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS.
Secondary outcome measures
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
+7 moreTrial 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.
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Who is running the clinical trial?
Vasgene Therapeutics, IncLead Sponsor
7 Previous Clinical Trials
241 Total Patients Enrolled
Carl Millner, M.D.Principal InvestigatorAIDS Healthcare Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a serious infection or been treated for one, except for oral thrush or genital herpes, in the last 14 days.I am committed to using two forms of birth control and agree to regular pregnancy tests if I can become pregnant.I have skin lesions suitable for biopsy and at least five others that haven't improved in a month.I haven't had cancer treatment for Kaposi's sarcoma in the last 4 weeks, or I've recovered from its side effects.I do not have brain metastases.Your platelet count is at least 75,000 per microliter.My kidney function, measured by creatinine or its clearance, is within the normal range.You have had allergic reactions to drugs similar to sEphB4-HSA or other drugs used in the study.You are expected to live for at least 3 more months.I need immediate strong therapy for my Kaposi Sarcoma because it's causing symptoms or affecting my daily activities.The levels of AST and ALT in your blood should be no more than 2.5 times the upper limit of normal.Your bilirubin levels should not be higher than 1.5 times the upper limit of normal.I can take care of myself but might not be able to do active work.I only use steroids for adrenal insufficiency, low testosterone, or asthma.I have not had a major heart attack or stroke in the last 6 months.Your heart's electrical activity (measured by EKG) shows a prolonged QT interval.I have Kaposi's sarcoma confirmed by a skin biopsy.My blood pressure is controlled and below 140/90 mm Hg, with or without medication.I haven't had serious bleeding or needed a blood transfusion in the last 6 months.I am not on warfarin or full dose blood thinners, but low dose is okay.I am HIV positive and have been on a stable HIV treatment for at least 12 weeks.I have had a stroke or mini-stroke in the last year.I do not have serious heart conditions like severe heart failure, unstable chest pain, or irregular heartbeats.If you have HIV, you can still participate in the study regardless of your CD4 count.I am currently receiving treatment for another cancer.I have tried or cannot tolerate certain cancer treatments.I am not pregnant, lactating, or breastfeeding.I am able to understand and give informed consent.I have been cancer-free for 2 years, except for basal cell skin cancer, cervical or anal carcinoma in situ.If you are HIV negative, you need to have a negative result from an HIV test taken within the last 4 weeks before joining the study. If the first test is positive, you need to have additional tests to confirm your HIV status.You must provide documentation of your HIV status. If you are HIV positive, you will not be able to participate in the study.I have Kaposi's sarcoma and my treated lesion has gotten worse.I am 18 years old or older.Your white blood cell count needs to be at least 1,000 per microliter.My Kaposi Sarcoma hasn't improved in the last 3 months, but it has gotten worse in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Study Drug
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are partaking in this clinical experiment?
"Indeed, clinicaltrials.gov data indicates that this medical trial is open for enrollment. It was initially posted on September 17th 2020 and updated lastly on October 11th 2022. 65 participants need to be sourced from 3 distinct locales."
Answered by AI
What are the potential hazards associated with sEphB4-HSA?
"Our experts at Power gave sEphB4-HSA a score of 2 on the safety scale, as this is an exploratory Phase 2 trial with some evidence in terms of security but none for efficacy."
Answered by AI
What makes this clinical trial unique compared to other similar experiments?
"Since 2015, sEphB4-HSA has been the object of scientific inquiry. After Vasgene Therapeutics' initial trial in 2015 with 61 participants, this agent was granted Phase 1 drug approval. There are presently seven active research projects for sEphB4-HSA spanning over 20 cities and one country."
Answered by AI
Is there an existing corpus of research encompassing sEphB4-HSA?
"sEphB4-HSA initially received attention in 2015 at Hoag Memorial Hospital Presbyterian. As of yet, no trials have reached completion; however, 7 studies are actively recruiting with several located within the city limits of Dallas, Texas."
Answered by AI
Is enrollment for this study open at the moment?
"Affirmative. The clinicaltrials.gov portal reveals that this trial, which was first published on September 17th 2020, is continuing to search for participants. 65 individuals need to be selected from 3 separate medical centres."
Answered by AI
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