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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03993106
Other study ID # 101
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 17, 2020
Est. completion date June 2025

Study information

Verified date April 2024
Source Vasgene Therapeutics, Inc
Contact Sarah E. Cole, M.S.
Phone 626-840-7756
Email scoleemail@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to learn if sEphB4-HSA will decrease the number or size of Kaposi sarcoma lesions in people.


Description:

sEphB4-HSA will be given through an intravenous infusion (into a vein). Each cycle of sEphB4-HSA will be 28 days (4 weeks). Each cycle of the study drug includes administration of 2 doses of sEphB4-HSA given on Days 1 and 15 of each cycle. Participants may continue on study protocol as long as their KS is continuing to respond or is clinically stable on study medication. Patients may come off treatment for the following reasons: - Disease progression. - Need for more than 2 dose reductions for toxicity. - Dose delay more than 28 days. - Patient withdraws consent. - Study termination by the Sponsor. - Participants who are noncompliant with respect to taking drugs, keeping appointments, or having tests required for the evaluation of drug safety and efficacy. - Participant's condition renders them unacceptable for further treatment in the judgment of the investigator.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
sEphB4-HSA
sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.

Locations

Country Name City State
United States AIDS Healthcare Foundation Beverly Hills California
United States UT Southwestern Medical Center Dallas Texas
United States CAN (Community AIDS Network) Community Health Sarasota Florida

Sponsors (1)

Lead Sponsor Collaborator
Vasgene Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS. The observed proportions of participants experiencing clinical response and unacceptable toxicity will be calculated with 95% confidence intervals. For clinical response, the Kaplan-Meier method will be used to estimate the distribution for time to death assessed for up to 1 month after treatment completion; for time to progression assessed from chemotherapy initiation to first documented progression up to 1 month after treatment completion; and for time to response assessed from the first dose until first documented response up to 1 month after completion of treatment. The Kaplan-Meier method will then be used to estimate the distribution of time to response, time to relapse, and time to death. Adverse events will be tabulated according to type and severity. Every 4 weeks until study completion (average 6 months).
Secondary Effects of sEphB4-HSA on tumor cell apoptosis and proliferation. Immunohistochemistry will be performed on biopsy samples and levels will be determine pre and post sEphB4-HSA. Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days).
Secondary Effects of sEphB4-HSA on immune response as measured in blood Peripheral blood samples will be used for flow cytometric analysis, cytokine measurements, and in vitro studies of T cells. Biopsy samples will be used to perform cytokine assays and evaluate for tumor regression and immune infiltration. Blood draws at baseline, Cycle 1 Days 1 & 15 (one cycle is 28 days) and Day 1 of Cycles 4, 7, 10 and at study completion (average of 6 months)
Secondary Effects of sEphB4-HSA on immune response as measured in tissue Biopsy samples will be used to perform cytokine assays and evaluate for tumor regression and immune infiltration. Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days).
Secondary Effects of sEphB4-HSA on viral replication and gene expression of human herpes virus-8 (HHV-8). HHV-8 copy number in peripheral blood mononuclear cells (PBMC) and plasma will be assessed by real-time quantitative RT-PCR. The same assay will also investigate a set of known endothelial-specific mRNAs (targeted array). Baseline, Cycle 1, Day 1, Day 1 of every third cycle (one cycle is 28 days) thereafter and at study completion (average of 6 months).
Secondary Changes in the VEGF-Notch-EphrinB2 angiogenic pathway Optional biopsies will be taken and immunohistochemistry will be performed to determine expression for genes in the VEGF-Notch-EphrinB2 pathway. At study entry and week 8-12 of study drug.
Secondary Trough levels of recombinant sEphB4-HSA fusion protein Trough levels (lowest concentration of sEphB4-HSA in the participant's bloodstream). sEphB4-HSA levels will be measured from blood draws on which ELISA will be run. Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days)
Secondary Cmax levels of recombinant sEphB4-HSA fusion protein Cmax levels (highest concentration of sEphB4-HSA in the participant's bloodstream). sEphB4-HSA levels will be measured from blood draws on which ELISA will be run. Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days)
Secondary Quality of Life Questionnaire Five measures of overall quality of life will be scored: physical well-being, emotional well-being, functional and global well-being, social well-being, and cognitive functioning. Changes in these measures will be assessed over time. Baseline, day 1 of study drug, day 1 of Cycle 4 (one cycle is 28 days), at study completion (average of 6 months)
Secondary Samples for banking Archive peripheral blood mononuclear cells (PBMCs) and tissue samples to be used in conjunction with samples collected in subsequent trials of sEphB4-HSA for future studies including identification of biomarkers predictive of response Optional skin biopsies at baseline, Cycle 1 Day 1 and any Day Cycle 3 (one cycle is 28 days). Blood draws at baseline, Cycle 1 Days 1 & 15 and Day 1 of Cycles 4, 7, 10 and at study completion (average of 6 months)
Secondary Effects of sEphB4-HSA on human immunodeficiency virus (HIV) plasma viral loads in participants with HIV Peripheral blood will be drawn and viral loads and T-cell counts will be performed. Baseline, Cycle 1, Day 1, Day 1 of every third cycle thereafter (one cycle is 28 days) and at study completion (average of 6 months).
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