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sEphB4-HSA in Treating Patients With Kaposi Sarcoma

Primary Purpose

Skin Kaposi Sarcoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Pharmacological Study
Quality-of-Life Assessment
Recombinant EphB4-HSA Fusion Protein
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Kaposi Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

    • 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, participants must be on a stable antiretroviral regimen for at least 12 weeks prior to study enrollment
  • There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is evidence for progression of KS in the 4 weeks immediately prior to study enrollment
  • Participants must, in the opinion of the investigator, be capable of complying with the protocol

Exclusion Criteria:

  • 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
  • Female participants who are pregnant, lactating, or breast-feeding
  • 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 electrocardiograms (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 uncontrolled sustained hypertension which will be defined as systolic blood pressure > 140, and diastolic blood pressure > 90, even with use of anti-hypertensive medications
  • 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 and low dose anticoagulants 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
  • Proteinuria as defined as > 2+ on urine dipstick; if dipstick urinalysis shows >= 2+ proteinuria, 24-hour urine for protein must be < 2 grams
  • Participants with diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months, or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the participant at undue risk for treatment related complications
  • 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

Sites / Locations

  • UC San Diego Moores Cancer CenterRecruiting
  • UCSD Moores Cancer CenterRecruiting
  • UCLA CARE Center
  • University of MiamiRecruiting
  • Grady Health SystemRecruiting
  • John H. Stroger Jr., Hospital of Cook CountyRecruiting
  • Johns Hopkins UniversityRecruiting
  • Washington UniversityRecruiting
  • Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (recombinant EphB4-HSA fusion protein)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Proportion of participants experiencing unacceptable toxicity
Adverse events will be tabulated according to type and severity.

Secondary Outcome Measures

Pharmacodynamic parameters of recombinant EphB4-HSA fusion protein
Descriptive statistics and graphical displays will be used to evaluate correlation between response and pharmacodynamics of EphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in trough levels, pharmacodynamic endpoints, viral copy number, protein expression and activation status, and finally immune cell counts and activation status will be investigated using the nonparametric Wilcoxon rank sum test.
Trough levels of recombinant EphB4-HSA fusion protein
Descriptive statistics and graphical displays will be used to evaluate correlation between response and trough levels of EphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in trough levels, pharmacodynamic endpoints, viral copy number, protein expression and activation status, and finally immune cell counts and activation status will be investigated using the nonparametric Wilcoxon rank sum test.

Full Information

First Posted
February 9, 2016
Last Updated
June 26, 2023
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), Vasgene Therapeutics, Inc, The Emmes Company, LLC, University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT02799485
Brief Title
sEphB4-HSA in Treating Patients With Kaposi Sarcoma
Official Title
A Phase II Study of sEphB4-HSA in Kaposi Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), Vasgene Therapeutics, Inc, The Emmes Company, LLC, University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the clinical response and toxicity of recombinant EphB4-HSA fusion protein (sEphB4-HSA) (at initial dosing of 15 mg/kg every 2 weeks) in participants with Kaposi sarcoma. SECONDARY OBJECTIVES: I. To assess the safety of sEphB4-HSA in participants with Kaposi sarcoma (KS). II. To determine trough level exposure of sEphB4-HSA and correlate with tumor response. III. To characterize the pharmacodynamics of sEphB4-HSA and correlate these effects with clinical response. IV. Effects on viral replication and gene expression of human herpes virus-8 (HHV-8). V. Changes in vascular endothelial growth factor (VEGF)-Notch-EphrinB2 angiogenic pathway. VI. Effects on immune response and modulation. VII. Effects on tumor cell apoptosis and proliferation. VIII. Effects on sEphB4-HSA on human immunodeficiency virus (HIV) plasma viral loads in participants with HIV. IX. To 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. X. To evaluate the clinical response and toxicity of sEphB4-HSA (at increased dosing of 10 mg/kg every week) in participants with KS. TERTIARY OBJECTIVES: I. Describe baseline quality of life (QOL) scores, using the functional assessment of HIV Infection (FAHI) + Kaposi sarcoma (KS) questionnaire, in participants with KS, and explore changes in QOL of participants on treatment with sEphB4-HSA. OUTLINE: Patients receive recombinant EphB4-HSA fusion protein intravenously (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. After completion of study treatment, patients are followed up for 1 month; patients with partial response or better are followed up every 3 months for up to 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Kaposi Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (recombinant EphB4-HSA fusion protein)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Intervention Type
Behavioral
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Biological
Intervention Name(s)
Recombinant EphB4-HSA Fusion Protein
Other Intervention Name(s)
sEphB4-HSA
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of participants experiencing clinical response
Description
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.
Time Frame
4 weeks (after 2 courses) and up to 12 months (end of follow-up)
Title
Proportion of participants experiencing unacceptable toxicity
Description
Adverse events will be tabulated according to type and severity.
Time Frame
Up to 12 months (end of follow-up)
Secondary Outcome Measure Information:
Title
Pharmacodynamic parameters of recombinant EphB4-HSA fusion protein
Description
Descriptive statistics and graphical displays will be used to evaluate correlation between response and pharmacodynamics of EphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in trough levels, pharmacodynamic endpoints, viral copy number, protein expression and activation status, and finally immune cell counts and activation status will be investigated using the nonparametric Wilcoxon rank sum test.
Time Frame
Days 1 and 15 of courses 1 and 2; days 1, 8, 15, and 22 of 1st 2 courses at escalated dose
Title
Trough levels of recombinant EphB4-HSA fusion protein
Description
Descriptive statistics and graphical displays will be used to evaluate correlation between response and trough levels of EphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in trough levels, pharmacodynamic endpoints, viral copy number, protein expression and activation status, and finally immune cell counts and activation status will be investigated using the nonparametric Wilcoxon rank sum test.
Time Frame
Days 1 and 15 of courses 1 and 2; days 1, 8, 15, and 22 of 1st 2 courses at escalated dose
Other Pre-specified Outcome Measures:
Title
Overall quality of life, assessed using the KS Functional Assessment of HIV questionnaire
Description
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. For KS-specific symptoms, responses may be dichotomized to reflect positive or negative impact of these symptoms. General estimating equations using a log-binomial model will be used to assess changes in these symptoms over time.
Time Frame
Baseline, day 1, day 1 of course 4, 12 months (end of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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, participants must be on a stable antiretroviral regimen for at least 12 weeks prior to study enrollment There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is evidence for progression of KS in the 4 weeks immediately prior to study enrollment Participants must, in the opinion of the investigator, be capable of complying with the protocol Exclusion Criteria: 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 Female participants who are pregnant, lactating, or breast-feeding 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 electrocardiograms (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 uncontrolled sustained hypertension which will be defined as systolic blood pressure > 140, and diastolic blood pressure > 90, even with use of anti-hypertensive medications 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 and low dose anticoagulants 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 Proteinuria as defined as > 2+ on urine dipstick; if dipstick urinalysis shows >= 2+ proteinuria, 24-hour urine for protein must be < 2 grams Participants with diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months, or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the participant at undue risk for treatment related complications 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ida Wong-Sefidan
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Phone
858-822-6276
Email
icwong@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ida C. Wong-Sefidan
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrienne Suazo
Phone
858-822-5354
Email
cancercto@ucsd.edu
First Name & Middle Initial & Last Name & Degree
William Wachsman, MD, PhD
Facility Name
UCLA CARE Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Terminated
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Ann Lynch
Phone
305-243-9448
Email
tlynch@miami.edu
First Name & Middle Initial & Last Name & Degree
Juan C Ramos, MD
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quin Boynes
Phone
404-778-1319
Email
quin.l.boynes@emory.edu
First Name & Middle Initial & Last Name & Degree
Joan Cain, MD
Facility Name
John H. Stroger Jr., Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Rubinstein, MD
Phone
312-864-7277
Email
prubinstein@cookcountyhhs.org
First Name & Middle Initial & Last Name & Degree
Paul Rubinstein, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Clark, PA-C
Phone
410-502-5396
Email
lclark53@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Richard Ambinder, MD
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Ratner, M.D.
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Lee Ratner, M.D.
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin Anderson
Phone
206-341-8940
Email
austin.anderson@virginiamason.org
First Name & Middle Initial & Last Name & Degree
David Aboulafia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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sEphB4-HSA in Treating Patients With Kaposi Sarcoma

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