Your session is about to expire
← Back to Search
Virus Therapy
sEphB4-HSA for Kaposi Sarcoma
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks (after 2 courses) and up to 12 months (end of follow-up)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have Kaposi's sarcoma confirmed by a biopsy, affecting my skin and possibly other organs.
Select...
I have documentation of my HIV status, positive or negative.
Select...
I have skin lesions that can be biopsied and others that haven't improved in a month.
Select...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
Select...
I am mostly self-sufficient and can carry out daily activities.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants experiencing clinical response
Proportion of participants experiencing unacceptable toxicity
Secondary outcome measures
Pharmacodynamic parameters of recombinant EphB4-HSA fusion protein
Trough levels of recombinant EphB4-HSA fusion protein
Other outcome measures
Overall quality of life, assessed using the KS Functional Assessment of HIV questionnaire
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
Find a Location
Who is running the clinical trial?
AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
9,606 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,834 Total Patients Enrolled
Vasgene Therapeutics, IncIndustry Sponsor
7 Previous Clinical Trials
286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for more than 3 months.I do not have severe diabetes, COPD requiring recent hospitalization, or conditions that make treatment risky for me.I have Kaposi's sarcoma confirmed by a biopsy, affecting my skin and possibly other organs.Your white blood cell count must be at least 1,500/mcL.Your platelet count is at least 100,000 per microliter.Your AST and ALT levels in the blood are not more than 2.5 times the upper limit of normal.I have not had a serious infection or been treated for one in the last 14 days.I have been cancer-free for less than 2 years, with certain exceptions.I am receiving growth factor support.I have documentation of my HIV status, positive or negative.I haven't had cancer treatment for KS in the last 4 weeks or still have side effects from treatments over 4 weeks ago.I am not on high-dose blood thinners but may be on low-dose ones.I have severe heart failure symptoms.I have Kaposi's sarcoma and my treated lesion has gotten worse.I have not had a major heart attack or stroke in the last 6 months.I haven't had any serious bleeding or needed a blood transfusion in the last 6 months.I have skin lesions that can be biopsied and others that haven't improved in a month.I am committed to using two forms of birth control and agree to regular pregnancy tests if I can become pregnant or if I am a man, to use condoms.If you test negative for HIV using an approved rapid test within 4 weeks before joining the study, that's okay. If the rapid test shows a positive result, you need to have additional approved tests to confirm your HIV status.My Kaposi's sarcoma hasn't improved in the last 3 months, but it has gotten worse in the last 4 weeks.Your total bilirubin level needs to be within a certain range.I do not have brain metastases.I have early-stage cervical cancer.My kidney function, measured by creatinine levels or clearance, is within the normal range.I have an irregular heartbeat.I am not pregnant, lactating, or breastfeeding.I have basal cell skin cancer.I am HIV positive and choose not to take antiretroviral therapy.I need immediate strong treatment for my Kaposi's sarcoma symptoms.I have either not been treated, or I've had treatments that didn't work or caused side effects.I have unstable chest pain.I am mostly self-sufficient and can carry out daily activities.Your heart's electrical activity, measured by EKG, should not be too slow or too fast. If the first EKG is too fast, it will be checked two more times.I am able to understand and give informed consent.My condition is early-stage anal cancer.You have had allergic reactions to similar medicines as sEphB4-HSA or other drugs used in the study.If you have HIV, you can participate in the study regardless of your CD4 count.I am only using steroids for adrenal insufficiency, low testosterone, or asthma.I am currently receiving treatment for another cancer.I am HIV positive and have been on a stable HIV treatment for at least 12 weeks.My blood pressure is high (>140/90) despite taking medication.You have a high level of protein in your urine, as indicated by a urine test. If the test shows high protein levels, a 24-hour urine test must show that you have less than 2 grams of protein in your urine.I do not have any heart-related illnesses.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (recombinant EphB4-HSA fusion protein)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks, if any, are associated with this pharmacological experiment?
"Our team has deemed the safety of Pharmacological Study to be a 2 on a scale from 1-3. This is because this Phase 2 trial holds clinical data confirming its security, yet there are no studies backing up its efficacy."
Answered by AI
How unique is this research endeavor?
"Pharmacological Study has been under research since 2015. The pioneering trial, which was funded by Vasgene Therapeutics, Inc., occurred in the same year and involved 61 participants. This successful Phase 1 drug approval paved the way for 7 ongoing studies spanning 20 cities over one nation today."
Answered by AI
What is the aggregate figure of participants involved in this trial?
"Affirmative. Clinicaltrials.gov indicates that, since it was first published on February 13th 2018, this research is actively looking to recruit 20 participants across 11 different sites."
Answered by AI
Are there current vacancies for individuals to join this clinical trial?
"Affirmative, according to clinicaltrials.gov this trial is open for recruitment having first been posted on February 13th 2018 and recently updated June 22nd 2022. The aim of the study is to enrol 20 patients from 11 sites."
Answered by AI
How many medical centers are hosting this scientific experiment?
"This investigation is recruiting participants from Johns Hopkins in Baltimore, Maryland; John Hopkins University in Seattle, Washington; and Virginia Mason Medical Center in Atlanta Georgia. Additionally, there are 11 other sites that have been selected to participate."
Answered by AI
Is Pharmacological Study only just emerging in the literature, or have there been prior investigations?
"Currently, 7 clinical trials are taking place that assess Pharmacological Study with none of them in the third phase. 28 different sites are hosting these trials and most of them can be found near Newport Beach, California."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger