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

This study has been completed.
Information provided by (Responsible Party):
CytRx Identifier:
First received: January 6, 2014
Last updated: October 18, 2016
Last verified: October 2016
This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV positive subjects with Kaposi's sarcoma.

Condition Intervention Phase
Kaposi's Sarcoma
HIV Positive
Drug: aldoxorubicin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Phase 2 Study to Investigate Efficacy, Safety, and Intratumoral Kinetics of ALDOXORUBICIN in HIV-Infected Patients With Kaposi's Sarcoma

Resource links provided by NLM:

Further study details as provided by CytRx:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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

  • Safety [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    To evaluate the safety of ALDOXORUBICIN in this population, assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight.

Secondary Outcome Measures:
  • Kinetics [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    To evaluate the intratumoral kinetics of ALDOXORUBICIN and related biomarker expression through sequential biopsies of KS skin lesions.

  • Performance Status [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    To determine the change in performance status (PS) as measured by the Karnofsky Performance Status (KPS).

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the change in quality of life as measured by the KS Functional Assessment of HIV (FAHI) Quality of Life instrument (QoLI)

Enrollment: 16
Study Start Date: January 2014
Study Completion Date: October 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aldoxorubicin
Subjects will receive either 100 or 150 mg/m2 (75, and 110 mg/m2 doxorubicin equivalents) by intravenous infusion (IVI) to 10 subjects in each group.
Drug: aldoxorubicin
Other Name: INNO-206

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02029430

United States, Louisiana
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
  More Information

Responsible Party: CytRx Identifier: NCT02029430     History of Changes
Other Study ID Numbers: ALDOXORUBICIN-P2-KS-01 
Study First Received: January 6, 2014
Last Updated: October 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by CytRx:
HIV positive
Kaposi's sarcoma

Additional relevant MeSH terms:
HIV Seropositivity
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016