This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV positive subjects with Kaposi's sarcoma.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
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.
Time frame: 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)
Time frame: 30 days from last dose, up to 199 days
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