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

Phase 2

Completed

• Conditions: HIV Positive; Kaposi's Sarcoma; AIDS
• Interventions: Drug: 150 mg/m2 aldoxorubicin; Drug: 50 mg/m2 aldoxorubicin; Drug: 100 mg/m2 aldoxorubicin

• Registration Number: NCT02029430
• Lead Sponsor: ImmunityBio, Inc.

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.

Study Timeline

• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Study Start: 2014-04-03
• Primary Completion: 2016-04-25
• Study Completion: 2016-04-25
• Status Verified: 2016-10
• Results First Submitted: 2024-04-05
• Results First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Results First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age ≥18 years of age; male or female.
2. HIV (confirmed by ELISA and western blot) with histologically confirmed KS.
3. Willing to undergo serial tumor biopsies.
4. Capable of providing informed consent and complying with trial procedures.
5. KPS ≥70 (Appendix B)
6. Easter Cooperative Oncology Group (ECOG) PS 0-2.
7. Life expectancy ≥ 8 weeks.
8. Measurable (at accessible site or radiographic) tumor lesions according to ACTG TIS criteria.
9. 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.)
10. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
11. Geographic accessibility to the site.

Exclusion Criteria

1. Prior exposure to an anthracycline.
2. Surgery and/or radiation treatment < 4 weeks prior to Randomization.
3. Exposure to any investigational agent within 30 days of Randomization.
4. 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.
5. 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.
6. 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.
7. Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
8. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
9. History or signs of active coronary artery disease with or without angina pectoris.
10. Serious myocardial dysfunction defined as ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45% of predicted institutional normal value.
11. Active, clinically significant serious infection requiring treatment with antibacterial, antiviral (other than antiretroviral therapy), or antifungal therapy.
12. Major surgery within 4 weeks prior to Randomization.
13. Any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
14. Any condition that is unstable and could jeopardize the subject's participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
150 mg/m2 aldoxorubicin	150 mg/m2 aldoxorubicin	-
50 mg/m2 aldoxorubicin	50 mg/m2 aldoxorubicin	-
100 mg/m2 aldoxorubicin	100 mg/m2 aldoxorubicin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population	30 days from last dose, up to 199 days	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)
Objective Response Rate	up to 6 months	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.

Trial Locations

Locations (1)

Louisiana State University Health Science Center; 🇺🇸 New Orleans, Louisiana, United States