sEphB4-HSA for Kaposi's Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Kaposi's SarcomasEphB4-HSA - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a protein which is naturally found in the body may help treat Kaposi sarcoma.

Eligible Conditions
  • Kaposi's Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Every 4 weeks until study completion (average 6 months).

Week 8
Changes in the VEGF-Notch-EphrinB2 angiogenic pathway
Month 6
Effects of sEphB4-HSA on viral replication and gene expression of human herpes virus-8 (HHV-8).
Month 6
Effects of sEphB4-HSA on human immunodeficiency virus (HIV) plasma viral loads in participants with HIV
Month 6
Quality of Life Questionnaire
Month 6
Effects of sEphB4-HSA on immune response as measured in blood
Day 28
Cmax levels of recombinant sEphB4-HSA fusion protein
Trough levels of recombinant sEphB4-HSA fusion protein
Month 6
Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS.
Month 6
Samples for banking
Day 28
Histocompatibility Antigens Class II
Effects of sEphB4-HSA on tumor cell apoptosis and proliferation.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Study Drug
1 of 1

Experimental Treatment

65 Total Participants · 1 Treatment Group

Primary Treatment: sEphB4-HSA · No Placebo Group · Phase 2

Study Drug
Drug
Experimental Group · 1 Intervention: sEphB4-HSA · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 4 weeks until study completion (average 6 months).

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

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study participants may have received one or more prior therapies, including but not limited to liposomal doxorubicin.
Participants must have KS involving skin, either with or without visceral involvement.
If you are HIV-positive, you are allowed to participate in the study regardless of your CD4 count.
The patient has an ECOG performance status of ≤ 2 or a Karnofsky performance score (KPS) of ≥ 50%.
The patient has a life expectancy of more than three months.
The absolute neutrophil count is ≥ 1,000/mcL.
The total bilirubin is less than or equal to 1.5 times the upper limit of normal.
The level of AST (SGOT) and ALT (SGPT) in the blood should not exceed 2.5 times the upper limit of the normal range.