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

AIDS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029430
• Other study ID #: ALDOXORUBICIN-P2-KS-01
• Status: Completed
• Phase: Phase 2
• Start date: April 3, 2014
• Est. completion date: April 25, 2016

Study information

• Verified date: October 2016
• Source: ImmunityBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 25, 2016
• Est. primary completion date: April 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• HIV Positive
• HIV Seropositivity
• Kaposi's Sarcoma
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• 50 mg/m2 aldoxorubicin

• 100 mg/m2 aldoxorubicin

• 150 mg/m2 aldoxorubicin

Locations

Country	Name	City	State
United States	Louisiana State University Health Science Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
ImmunityBio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	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.; Objective responses will be evaluated using the RECIST 1.1 criteria. Changes (i.e. improvements) in tumor measurements from baseline values will be assigned a status of CR or PR or SD. Objective response measurements will comprise the sum of CR plus PR.; Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm).; Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.	up to 6 months
Primary	Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population	All subjects who receive any amount of ALDOXORUBICIN will be included in the safety analyses, which will include the following: The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.; vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area); physical examination; laboratory tests (chemistry, hematology, urinalysis, anion gap)	30 days from last dose, up to 199 days