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A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma

Primary Purpose

Kaposi's Sarcoma, HIV Positive, AIDS

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

aldoxorubicin

About this trial

This is an interventional treatment trial for Kaposi's Sarcoma focused on measuring HIV positive, AIDS, Kaposi's sarcoma, Sarcoma, tumor, cancer

Eligibility Criteria

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

Inclusion Criteria:

Age ≥18 years of age; male or female.
HIV (confirmed by ELISA and western blot) with histologically confirmed KS.
Willing to undergo serial tumor biopsies.
Capable of providing informed consent and complying with trial procedures.
KPS ≥70 (Appendix B)
Easter Cooperative Oncology Group (ECOG) PS 0-2.
Life expectancy ≥ 8 weeks.
Measurable (at accessible site or radiographic) tumor lesions according to ACTG TIS criteria.
Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
Geographic accessibility to the site.

Exclusion Criteria:

Prior exposure to an anthracycline.
Surgery and/or radiation treatment < 4 weeks prior to Randomization.
Exposure to any investigational agent within 30 days of Randomization.
History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥3 years.
Laboratory values: Screening serum creatinine >1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) > 2.5 × ULN, total bilirubin >1.5 × ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <75,000/mm3, absolute lymphocyte count <1000/mm3, hematocrit level <25% for females or <27% for males, serum albumin ≤2.5 g/dL.
Evidence of central nervous system (CNS) hemorrhage National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (published 28 May 2009) grade 2 or greater on baseline MRI.
Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
History or signs of active coronary artery disease with or without angina pectoris.
Serious myocardial dysfunction defined as ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45% of predicted institutional normal value.
Active, clinically significant serious infection requiring treatment with antibacterial, antiviral (other than antiretroviral therapy), or antifungal therapy.
Major surgery within 4 weeks prior to Randomization.
Any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
Any condition that is unstable and could jeopardize the subject's participation in the study.

Sites / Locations

Louisiana State University Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aldoxorubicin

Arm Description

Subjects will receive either 100 or 150 mg/m2 (75, and 110 mg/m2 doxorubicin equivalents) by intravenous infusion (IVI) to 10 subjects in each group.

Outcomes

Primary Outcome Measures

Objective Response Rate

To evaluate the uptake of aldoxorubicin into the tumor and the objective response rate (complete and partial response) using RECIST 1.1 criteria in subjects with HIV-infected with Kaposi's sarcoma

Safety

To evaluate the safety of ALDOXORUBICIN in this population, assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight.

Secondary Outcome Measures

Kinetics

To evaluate the intratumoral kinetics of ALDOXORUBICIN and related biomarker expression through sequential biopsies of KS skin lesions.

Performance Status

To determine the change in performance status (PS) as measured by the Karnofsky Performance Status (KPS).

Quality of Life

To determine the change in quality of life as measured by the KS Functional Assessment of HIV (FAHI) Quality of Life instrument (QoLI)

Full Information

NCT ID

NCT02029430

First Posted

January 6, 2014

Last Updated

January 27, 2022

Sponsor

ImmunityBio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02029430

Brief Title

A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma

Official Title

An Open-Label Pilot Phase 2 Study to Investigate Efficacy, Safety, and Intratumoral Kinetics of ALDOXORUBICIN in HIV-Infected Patients With Kaposi's Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ImmunityBio, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV positive subjects with Kaposi's sarcoma.

Detailed Description

This is an open-label pilot phase 2 study to investigate efficacy, safety, and intratumoral kinetics of aldoxorubicin in HIV-Infected patients with Kaposi's sarcoma.

6. Conditions and Keywords

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

Kaposi's Sarcoma, HIV Positive, AIDS

Keywords

HIV positive, AIDS, Kaposi's sarcoma, Sarcoma, tumor, cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aldoxorubicin

Arm Type

Experimental

Arm Description

Subjects will receive either 100 or 150 mg/m2 (75, and 110 mg/m2 doxorubicin equivalents) by intravenous infusion (IVI) to 10 subjects in each group.

Intervention Type

Drug

Intervention Name(s)

aldoxorubicin

Other Intervention Name(s)

INNO-206

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

To evaluate the uptake of aldoxorubicin into the tumor and the objective response rate (complete and partial response) using RECIST 1.1 criteria in subjects with HIV-infected with Kaposi's sarcoma

Time Frame

up to 6 months

Title

Safety

Description

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Kinetics

Description

To evaluate the intratumoral kinetics of ALDOXORUBICIN and related biomarker expression through sequential biopsies of KS skin lesions.

Time Frame

up to 6 months

Title

Performance Status

Description

To determine the change in performance status (PS) as measured by the Karnofsky Performance Status (KPS).

Time Frame

up to 6 months

Title

Quality of Life

Description

To determine the change in quality of life as measured by the KS Functional Assessment of HIV (FAHI) Quality of Life instrument (QoLI)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years of age; male or female. HIV (confirmed by ELISA and western blot) with histologically confirmed KS. Willing to undergo serial tumor biopsies. Capable of providing informed consent and complying with trial procedures. KPS ≥70 (Appendix B) Easter Cooperative Oncology Group (ECOG) PS 0-2. Life expectancy ≥ 8 weeks. Measurable (at accessible site or radiographic) tumor lesions according to ACTG TIS criteria. Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.) Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Geographic accessibility to the site. Exclusion Criteria: Prior exposure to an anthracycline. Surgery and/or radiation treatment < 4 weeks prior to Randomization. Exposure to any investigational agent within 30 days of Randomization. History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥3 years. Laboratory values: Screening serum creatinine >1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) > 2.5 × ULN, total bilirubin >1.5 × ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <75,000/mm3, absolute lymphocyte count <1000/mm3, hematocrit level <25% for females or <27% for males, serum albumin ≤2.5 g/dL. Evidence of central nervous system (CNS) hemorrhage National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (published 28 May 2009) grade 2 or greater on baseline MRI. Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. History or signs of active coronary artery disease with or without angina pectoris. Serious myocardial dysfunction defined as ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45% of predicted institutional normal value. Active, clinically significant serious infection requiring treatment with antibacterial, antiviral (other than antiretroviral therapy), or antifungal therapy. Major surgery within 4 weeks prior to Randomization. Any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. Any condition that is unstable and could jeopardize the subject's participation in the study.

Facility Information:

Facility Name

Louisiana State University Health Science Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

12. IPD Sharing Statement

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A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma

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