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

NCT02029430 | Completed Phase 2 Results

• 1 other identifier: ALDOXORUBICIN-P2-KS-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kaposi's Sarcoma; HIV Positive; AIDS

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

50 mg/m2 aldoxorubicin

EXPERIMENTAL

Drug: 50 mg/m2 aldoxorubicin

100 mg/m2 aldoxorubicin

EXPERIMENTAL

Drug: 100 mg/m2 aldoxorubicin

150 mg/m2 aldoxorubicin

EXPERIMENTAL

Drug: 150 mg/m2 aldoxorubicin

Interventions

50 mg/m2 aldoxorubicin DRUG

50 mg/m2 aldoxorubicin

100 mg/m2 aldoxorubicin DRUG

100 mg/m2 aldoxorubicin

150 mg/m2 aldoxorubicin DRUG

150 mg/m2 aldoxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years of age; male or female.
• HIV (confirmed by ELISA and western blot) with histologically confirmed KS.
• Willing to undergo serial tumor biopsies.
• Capable of providing informed consent and complying with trial procedures.
• KPS ≥70 (Appendix B)
• Easter Cooperative Oncology Group (ECOG) PS 0-2.
• Life expectancy ≥ 8 weeks.
• Measurable (at accessible site or radiographic) tumor lesions according to ACTG TIS criteria.
• 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.)
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Geographic accessibility to the site.

You may not qualify if:

• Prior exposure to an anthracycline.
• Surgery and/or radiation treatment \< 4 weeks prior to Randomization.
• Exposure to any investigational agent within 30 days of Randomization.
• 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.
• 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.
• 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.
• Clinically evident congestive heart failure (CHF) \> class II of the New York Heart Association (NYHA) guidelines.
• Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
• History or signs of active coronary artery disease with or without angina pectoris.
• Serious myocardial dysfunction defined as ultrasound-determined absolute left ventricular ejection fraction (LVEF) \<45% of predicted institutional normal value.
• Active, clinically significant serious infection requiring treatment with antibacterial, antiviral (other than antiretroviral therapy), or antifungal therapy.
• Major surgery within 4 weeks prior to Randomization.
• Any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
• Any condition that is unstable and could jeopardize the subject's participation in the study.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Seropositivity; Acquired Immunodeficiency Syndrome; Sarcoma; Neoplasms

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: April 3, 2014
• Primary Completion: April 25, 2016
• Study Completion: April 25, 2016
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2016-10

Locations

US (1)