Kaposi's SarcomaPhase 2NCT02029430

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

A Phase 2 study testing 50 mg/m2 aldoxorubicin, 100 mg/m2 aldoxorubicin and 150 mg/m2 aldoxorubicin in people with Kaposi's Sarcoma and HIV Positive, run by ImmunityBio, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Kaposi's Sarcoma, HIV Positive, AIDS
What is being tested?: 50 mg/m2 aldoxorubicin, 100 mg/m2 aldoxorubicin and 150 mg/m2 aldoxorubicin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2014to 25 Apr 2016
Phase: Phase 2

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

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Louisiana State University Health Science Center
New Orleans, Louisiana, 70112

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About this study

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

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

Read the 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.

Conditions: Kaposi's Sarcoma, HIV Positive, AIDS
Being tested: 50 mg/m2 aldoxorubicin, 100 mg/m2 aldoxorubicin, 150 mg/m2 aldoxorubicin
Keywords: HIV positive, AIDS, Kaposi's sarcoma, Sarcoma, tumor, cancer
Medical subject headings: Sarcoma, Kaposi, HIV Seropositivity, Acquired Immunodeficiency Syndrome, Sarcoma, Neoplasms

What participants receive

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

50 mg/m2 aldoxorubicinDrug
100 mg/m2 aldoxorubicinDrug
150 mg/m2 aldoxorubicinDrug

Study groups in NCT02029430
Study group	Role	What they receive
50 mg/m2 aldoxorubicin	Experimental	Not described Receives: Drug: 50 mg/m2 aldoxorubicin
100 mg/m2 aldoxorubicin	Experimental	Not described Receives: Drug: 100 mg/m2 aldoxorubicin
150 mg/m2 aldoxorubicin	Experimental	Not described Receives: Drug: 150 mg/m2 aldoxorubicin

What is being measured

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

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.
Objective responses will be evaluated using the RECIST 1.1 criteria. Changes (i.e. improvements) in tumor measurements from baseline values will be assigned a status of CR or PR or SD. Objective response measurements will comprise the sum of CR plus PR.
Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm).
Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.
Measured: up to 6 months
Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population
All subjects who receive any amount of ALDOXORUBICIN will be included in the safety analyses, which will include the following:
The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.
- vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area)
- physical examination
- laboratory tests (chemistry, hematology, urinalysis, anion gap)
Measured: 30 days from last dose, up to 199 days

Timeline

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

3 Apr 201425 Apr 2016

First posted7 Jan 2014 (estimated)
Study start3 Apr 2014
Primary completion25 Apr 2016
Study completion25 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kaposi's SarcomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02029430
Sponsor's protocol ID: ALDOXORUBICIN-P2-KS-01
Status last verified: Oct 2016
First submitted: 6 Jan 2014
Last updated: 11 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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