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:

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.