Clinical Trials

MainTitle

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

This study has been completed
Sponsor
CytRx


Information provided by (Responsible Party)
CytRx
ClinicalTrials.gov Identifier
NCT02029430

First received: January 6, 2014
Last updated: October 18, 2016
Last Verified: October 2016
History of Changes
Purpose

Purpose

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+
HIV Positive
AIDS

Drug : aldoxorubicin
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by CytRx:

Primary Outcome Measures

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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

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 ClinicalTrials.gov identifier: NCT02029430

Locations

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

Sponsors and Collaborators

CytRx
More Information

More Information


Responsible Party: CytRx  
ClinicalTrials.gov Identifier: NCT02029430   History of Changes  
Other Study ID Numbers: ALDOXORUBICIN-P2-KS-01  
Study First Received: January 6, 2014  
Last Updated: October 18, 2016  

Keywords provided by CytRx:

HIV +
HIV positive
AIDS
Kaposi's sarcoma
Sarcoma
tumor
cancer

Additional relevant MeSH terms:
Sarcoma
HIV Seropositivity
Sarcoma, Kaposi
Doxorubicin

ClinicalTrials.gov processed this data on November 20, 2017
This information is provided by ClinicalTrials.gov.