A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma (NCT02029430) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: up to 6 months
2
Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population
. 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.