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Kaposi SarcomaPhase 2NCT03993106

A Study of sEphB4-HSA in Kaposi Sarcoma

A Phase 2 study testing sEphB4-HSA in people with Kaposi Sarcoma, run by Vasgene Therapeutics, Inc at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kaposi Sarcoma
What is being tested?
sEphB4-HSA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
3 sitesUnited States
Study dates
17 Sep 2020to Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants may be treatment naïve, refractory to, or intolerant of one or more prior therapies, or treated with prior systemic treatment including but not limited to liposomal doxorubicin.
  • Participants must have biopsy-proven KS involving skin, with or without visceral involvement.
  • If HIV-positive, any CD4 count will be allowed on study.
  • Age ≥ 18 years.
  • ECOG performance status ≤ 2 or Karnofsky performance score (KPS) ≥ 50%
  • Life expectancy of greater than 3 months.
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  • Absolute neutrophil count ≥ 1,000/mcL
  • Platelets ≥ 75,000/mcL
  • Total bilirubin ≤ 1.5 X ULN
  • AST (SGOT) / ALT (SGPT) ≤ 2.5 X ULN
  • 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.
  • Participants taking part in the optional biopsies must have cutaneous lesion(s) amenable to two (2) 5-mm tumor biopsy at study entry and optional second biopsy on therapy at week 8-12. Patients must have at least five additional lesions measurable for assessment with no improvement over the past month.
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to enrollment and again within 24 hours prior to starting Cycle 1 of sEphB4-HSA. Further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME during receipt of sEphB4-HSA, and 12 weeks after discontinuation of sEphB4-HSA. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
  • A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • 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 ELISA test kit, and confirmed by Western blot or other approved test, or HIV rapid multispot antibody differentiation assay). 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.
  • If the participant is HIV negative, documentation of a negative result for any federally approved, licensed HIV rapid test within 4 weeks prior to study enrollment will suffice. If the initial rapid test is positive, further approved confirmatory test results must be present to document the subject's HIV status.
  • If participant is HIV positive, participant must be on a stable antiretroviral regimen for at least 12 weeks prior to study enrollment.
  • There should be no evidence for improvement in Kaposi Sarcoma in the 3 months prior to study enrollment, unless there is evidence for progression of Kaposi Sarcoma in the 4 weeks immediately prior to study enrollment.
  • Participants must, in the opinion of the investigator, be capable of complying with the protocol.

Who cannot join

  • Inability to understand and inability to provide informed consent.
  • Participants who are receiving any other investigational agents.
  • Participants who have had anti-neoplastic treatment for KS (including chemotherapy, radiotherapy, local treatment including topical 5-FU, biological therapy or investigational therapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study OR those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • 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.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sEphB4-HSA or other agents used in study.
  • Concurrent, acute, active infection, or treatment for infection, other than oral thrush or genital herpes, within 14 days of enrollment. Mycobacterium avium complex (MAC) that is undergoing treatment is allowed.
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  • Participants for whom front-line cytotoxic therapy is indicated (i.e. symptomatic visceral or pulmonary Kaposi Sarcoma or symptomatic Kaposi Sarcoma impairing functional status).
  • Concurrent neoplasia requiring cytotoxic therapy.
  • Participant is ≤ 2 years free of another primary malignancy. Exceptions include the following:
  • Basal cell skin cancer
  • Cervical carcinoma in situ
  • Anal carcinoma in situ
  • Any steroid treatment except for that required for replacement therapy in adrenal insufficiency, topical or injected testosterone for hypogonadism, or inhaled steroids for the treatment of asthma.
  • Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since that local treatment. Any prior local treatment to indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion.
  • Female participants who are pregnant, lactating, or breast-feeding.
  • Pregnant women are excluded from this study because sEphB4-HSA has not been tested in pregnant women and it could have potential teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sEphB4-HSA, breastfeeding should be discontinued if the mother is treated with sEphB4-HSA.
  • Participants with a recent history (< 6 months) of a major infarct including but not inclusive to bowel ischemia, cerebral vascular accident, transient ischemic attack, myocardial infarction, limb ischemia, or skin necrosis.
  • Participants with a QTcF (Fridericia Correction Formula) > 480 ms on 2 out of 3 EKGs (if first EKG is < 480, no need to repeat, if first EKG is > 480 repeat twice for a total of 3 EKGs).
  • Participants with systolic blood pressure >120 mm Hg or diastolic blood pressure >80 mm Hg who are unwilling to start antihypertensives (see Section 5.4 uncontrolled sustained for recommendations for management of hypertension which will be defined as during the study), or participants with systolic blood pressure > 140, and mm Hg, or diastolic blood pressure > 90, even mm Hg, with or without use of anti-hypertensive medications. (participants may not enroll onto the study until BP is ≤ 140/90 mm Hg with or without antihypertensives).
  • Participants with a recent history (< 6 months) of a major bleed which will be defined as a symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level 2 grams/dL or more, or leading to transfusion of two or more units of whole blood or packed red cells.
  • Participants on any dose of warfarin or are on full dose anticoagulation with other agents including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within 7 days prior to study enrollment; participants on prophylactic doses of low molecular weight heparin are allowed.
  • Cardiac related illnesses including, but not limited to:
  • Symptomatic congestive heart failure including participants with Grade III/IV cardiac disease as defined by the New York Heart Association functional criteria
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Physical or psychiatric illness/social situations that in the estimation of the investigator would limit compliance with study requirements or place the participant at high risk of toxicity or non-compliance.
  • Patients with a history of CVA or TIA in the past 12 months

Trial locations and contacts

3 sites in 1 country.

Sarah E. Cole, M.S. contact

626-840-7756

scoleemail@gmail.com

United States3 sites, 3 recruiting

  • AIDS Healthcare Foundation

    Beverly Hills, California, 90211

    Werner De LaFayette, B.S., 323-913-1033, Werner.DeLafayette@aidshealth.org

    Carl Millner, M.D.

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Tianna Petersen, 214-590-0611, Tianna.petersen@utsouthwestern.edu

    Mamta Jain, M.D.

    Recruiting

  • CAN (Community AIDS Network) Community Health

    Sarasota, Florida, 34237

    Prerak Shukla, 941-366-0134 ext. 11102, pshukla@cancommunityhealth.org

    Corklin Steinhart, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Study of sEphB4-HSA in Kaposi Sarcoma

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.

Read the detailed 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.
Conditions
Kaposi Sarcoma
Being tested
sEphB4-HSA
Medical subject headings
Sarcoma, Kaposi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sEphB4-HSADrug

    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.

Study groups in NCT03993106
Study groupRoleWhat they receive
Study DrugExperimentalAll 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.
Receives: Drug: sEphB4-HSA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 4 weeks until study completion (average 6 months).

Secondary outcomes (10)

  1. 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.

    Measured: Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days).

  2. 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.

    Measured: 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)

  3. 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.

    Measured: Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days).

  4. 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).

    Measured: 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).

  5. 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.

    Measured: At study entry and week 8-12 of study drug.

  6. 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.

    Measured: Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days)

  7. 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.

    Measured: Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days)

  8. 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.

    Measured: Baseline, day 1 of study drug, day 1 of Cycle 4 (one cycle is 28 days), at study completion (average of 6 months)

  9. 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

    Measured: 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)

  10. 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2019
  2. Study start17 Sep 2020
  3. Primary completionDec 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03993106
Sponsor's protocol ID
101
Status last verified
Apr 2024
First submitted
25 May 2019
Last updated
2 May 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sEphB4-HSA in people with Kaposi Sarcoma, run by Vasgene Therapeutics, Inc at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sarah E. Cole, M.S. (626-840-7756, scoleemail@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS. (time frame: Every 4 weeks until study completion (average 6 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03993106.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.

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