Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma (NCT00427414) | Clinical Trial Compass
TerminatedPhase 1
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
Stopped: Terminated due to slow accrual.
United States, Brazil14 participantsStarted 2008-09
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating patients with HIV-related 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed Kaposi's sarcoma (KS) involving the following:
* Skin
* Lymph nodes (palpable disease only)
* Oral cavity
* Must have ≥ 5 measurable, previously nonirradiated, cutaneous lesions that can be used as indicator lesions
* Must have 2 lesions ≥ 5 x 5 mm that are accessible for 4 mm punch biopsy
* Serologically confirmed HIV positivity
* Concurrent antiretroviral therapy required, except for patients who have exhausted all available treatment options
* Must be on a stable dose for ≥ 4 weeks
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 3 months
* No other neoplasia requiring cytotoxic therapy
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior anthracycline therapy
* At least 4 weeks since prior antineoplastic treatment for KS, including any of the following:
* Chemotherapy (6 weeks for nitrosoureas or mitomycin C)
* Radiotherapy
* Local therapy
* Biological therapy
* Investigational therapy
* At least 60 days since prior local therapy of any KS indicator lesion unless lesion has clearly progressed since treatment
* No other concurrent investigational drugs, cytotoxic chemotherapy, or KS-specific treatment
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
Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors