A Study to Investigate ALDOXORUBICIN in HIV-infected 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.

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.