CClinicalTrials.gg
CompletedNCT00002147Updated Jun 24, 2005

Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

A Phase 3 interventional study of Doxorubicin hydrochloride (liposomal) in Sarcoma, Kaposi and HIV Infections, sponsored by Sequus Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Sequus Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

Read the detailed description

Patients receive DOX-SL every 3 weeks for up to 20 cycles.

02

Conditions studied

  • Sarcoma, Kaposi
  • HIV Infections

Keywords

  • Sarcoma, Kaposi
  • Liposomes
  • Doxorubicin
  • Acquired Immunodeficiency Syndrome
  • Drug Carriers
03

In context

Sarcoma, Kaposi

162 studies on the registry are indexed under Sarcoma, Kaposi; 29 are open to participants now.

Browse Sarcoma, Kaposi studies →

Lead sponsor

Sequus Pharmaceuticals is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • AIDS-related Kaposi's sarcoma that requires systemic chemotherapy.
  • EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL.

Prior Medication:

Allowed:

  • Prior anthracyclines.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Cardiac ejection fraction \< 50 percent or clinically significant cardiac disease.
  • Eligibility for a Liposomal Technology comparative protocol.

Concurrent Medication:

Excluded:

  • Other cytotoxic chemotherapy.

Patients with the following prior condition are excluded:

History of idiosyncratic or allergic reaction to anthracyclines.

Prior Medication:

Excluded:

  • Chemotherapy within the past 3 weeks.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • DrugDoxorubicin hydrochloride (liposomal)
06

Study locations

1 site
  • Sequus Pharmaceutical Inc
    Menlo Park, California 94025, United States
07

References and documents

Publications

  • Jablonowski H, Szelenyi H, Armbrecht C, Mauss S, Niederau C, Strohmeyer G. Liposomal doxorubicin--a new formulation for the treatment of Kaposi's sarcoma: a study on safety and efficacy in AIDS patients. Int Conf AIDS. 1993 Jun 6-11;9(1):397 (abstract no PO-B12-1573)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002147
Lead sponsor
Sequus Pharmaceuticals
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 1996. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion