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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02029430
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : October 19, 2016
Information provided by (Responsible Party):

Brief Summary:
This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV positive subjects with Kaposi's sarcoma.

Condition or disease Intervention/treatment Phase
Kaposi's Sarcoma HIV+ HIV Positive AIDS Drug: aldoxorubicin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : October 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: up to 6 months ]
    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

  2. Safety [ Time Frame: up to 6 months ]
    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 :
  1. Kinetics [ Time Frame: up to 6 months ]
    To evaluate the intratumoral kinetics of ALDOXORUBICIN and related biomarker expression through sequential biopsies of KS skin lesions.

  2. Performance Status [ Time Frame: up to 6 months ]
    To determine the change in performance status (PS) as measured by the Karnofsky Performance Status (KPS).

  3. Quality of Life [ Time Frame: 6 months ]
    To determine the change in quality of life as measured by the KS Functional Assessment of HIV (FAHI) Quality of Life instrument (QoLI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02029430

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

Responsible Party: CytRx Identifier: NCT02029430     History of Changes
Other Study ID Numbers: ALDOXORUBICIN-P2-KS-01
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

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