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Sponsored by: |
Sequus Pharmaceuticals |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002147 |
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.
Condition | Intervention | Phase |
Sarcoma, Kaposi HIV Infections |
Drug: Doxorubicin hydrochloride (liposomal) |
Phase III |
MedlinePlus related topics: | AIDS Kaposi's Sarcoma Soft Tissue Sarcoma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of idiosyncratic or allergic reaction to anthracyclines.
Prior Medication:
Excluded:
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)
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Study ID Numbers: | 134D, LTI-30-25 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002147 |
Health Authority: | United States: Food and Drug Administration |
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