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

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.

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:

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.