CompletedPhase 2

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

United States15 participantsStarted 2014-04-03

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Objective Response Rate

Timeframe: up to 6 months

Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population

Timeframe: 30 days from last dose, up to 199 days

NCT IDNCT02029430

SponsorImmunityBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04-25

Results submitted2024-04-05

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.