sEphB4-HSA in Treating Patients With Kaposi Sarcoma

NCT02799485 | Completed Phase 2 FDA Drug

• 5 other identifiers: AMC-096NCI-2015-00052096AMC 096U01CA121947
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

Brief Summary

This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating patients with Kaposi sarcoma. Recombinant EphB4-HSA fusion protein may block the growth of blood vessels that provide blood to the cancer, and may also prevent cancer cells from growing.

Conditions

Skin Kaposi Sarcoma

Outcome Measures

Primary Outcomes (2)

• Proportion of participants experiencing clinical response

  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. Time to response is the time from the first dose until documented first response. Time to progression is the time from first dose to first documented progression. Response duration is the time from first documented response to first documented progression.

  4 weeks (after 2 courses) and up to 12 months (end of follow-up)

• Proportion of participants experiencing unacceptable toxicity

  Adverse events will be tabulated according to type and severity.

  Up to 12 months (end of follow-up)

Secondary Outcomes (2)

• Pharmacodynamic parameters of recombinant EphB4-HSA fusion protein

  Days 1 and 15 of courses 1 and 2; days 1, 8, 15, and 22 of 1st 2 courses at escalated dose

• Trough levels of recombinant EphB4-HSA fusion protein

  Days 1 and 15 of courses 1 and 2; days 1, 8, 15, and 22 of 1st 2 courses at escalated dose

Other Outcomes (1)

• Overall quality of life, assessed using the KS Functional Assessment of HIV questionnaire

  Baseline, day 1, day 1 of course 4, 12 months (end of study)

Study Arms (1)

Treatment (recombinant EphB4-HSA fusion protein)

EXPERIMENTAL

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.

Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Behavioral: Quality-of-Life Assessment; Biological: Recombinant EphB4-HSA Fusion Protein

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (recombinant EphB4-HSA fusion protein)

Pharmacological Study OTHER

Correlative studies

Treatment (recombinant EphB4-HSA fusion protein)

Quality-of-Life Assessment BEHAVIORAL

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (recombinant EphB4-HSA fusion protein)

Recombinant EphB4-HSA Fusion Protein BIOLOGICAL

Given IV

Also known as: sEphB4-HSA

Treatment (recombinant EphB4-HSA fusion protein)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 cluster of differentiation (CD)4 count will be allowed on study
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 or Karnofsky performance score (KPS) \>= 60%
• Life expectancy of greater than 3 months
• Absolute neutrophil count \>= 1,500/mcL\*
• Participants may be receiving growth factor support to meet these criteria
• Platelets \>= 100,000/mcL
• Total bilirubin =\< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN
• Creatinine within normal institutional limit for the reference lab OR creatinine clearance \>= 60 mL/min/1.73 m\^2 as calculated by Cockcroft-Gault formula for participants with creatinine levels above institutional normal
• Participants must have cutaneous lesion(s) amenable to four (4) 5-mm tumor biopsies during the study (either 4 separate lesions measuring \>= 5 mm each OR 2 separate lesions measuring \>= 10 mm each) and 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 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

You may not qualify if:

• 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 fluorouracil \[5-FU\], 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
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sEphB4-HSA or other agents used in study
• Participants who refuse antiretroviral therapy for HIV, if HIV positive
• Concurrent, acute, active infection, or treatment for infection, other than oral thrush or genital herpes, within 14 days of enrollment
• Participants for whom front-line cytotoxic therapy is indicated (i.e. symptomatic visceral or pulmonary KS or symptomatic KS 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

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• Vasgene Therapeutics, Inc: collaborator
• The Emmes Company, LLC: collaborator
• University of Arkansas: collaborator

Study Sites (9)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

UCLA CARE Center

Los Angeles, California, 90025, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

John H. Stroger Jr., Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Study Officials

• Ida Wong-Sefidan

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: June 15, 2016
• Study Start: February 13, 2018
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)