A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

Study Description

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Brief Summary:

To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.

Condition or disease	Intervention/treatment	Phase
Sarcoma, Kaposi; HIV Infections	Drug: Doxorubicin hydrochloride (liposomal)	Phase 3

Detailed Description:

Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

Study Design

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Study Type :	Interventional (Clinical Trial)
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month.
• Maintenance therapy for tuberculosis, fungal, and herpes infections.
• Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
• Foscarnet or ganciclovir for CMV infection.
• Colony stimulating factors and erythropoietin.

Patients must have:

• Moderate to severe AIDS-related Kaposi's sarcoma.
• Documented anti-HIV antibody.
• No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).

NOTE:

• Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Clinically significant cardiac disease.
• Confusion or disorientation.

Concurrent Medication:

Excluded:

• Other cytotoxic cancer chemotherapy.

Patients with the following prior conditions are excluded:

• Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
• History of idiosyncratic or allergic reaction to anthracyclines.
• History of major psychiatric illness.

Prior Medication:

Excluded within the past 4 weeks:

• Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
• Interferon treatment.

Prior Treatment:

Excluded within the past 3 weeks:

• Radiation or electron beam therapy.

Contacts and Locations

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  Show 33 Study Locations

Sponsors and Collaborators

Sequus Pharmaceuticals

More Information

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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)

ClinicalTrials.gov Identifier:	NCT00002319 History of Changes
Other Study ID Numbers:	134C; LTI-30-12
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	January 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:

Sarcoma, Kaposi; Liposomes; Doxorubicin; Acquired Immunodeficiency Syndrome; Drug Carriers

Additional relevant MeSH terms:

HIV Infections; Sarcoma; Sarcoma, Kaposi; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type	Neoplasms; Herpesviridae Infections; DNA Virus Infections; Neoplasms, Vascular Tissue; Doxorubicin; Liposomal doxorubicin; Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action