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

• ClinicalTrials.gov Identifier: NCT00002319
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Sequus Pharmaceuticals
• Information provided by: NIH AIDS Clinical Trials Information Service

Tracking Information

• First Submitted Date: November 2, 1999
• First Posted Date: August 31, 2001
• Last Update Posted Date: June 24, 2005
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
• Official Title: Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma
• 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.
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sarcoma, Kaposi
• HIV Infections

• Intervention: Drug: Doxorubicin hydrochloride (liposomal)
• Study Arms: Not Provided
• 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)

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00002319
• Other Study ID Numbers: 134C; LTI-30-12
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Sequus Pharmaceuticals
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: NIH AIDS Clinical Trials Information Service
• Verification Date: January 1996