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

HIV Infections Clinical Trial

Official title:

Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002319
• Other study ID #: 134C
• Secondary ID: LTI-30-12
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Doxorubicin hydrochloride (liposomal)

Locations

Country	Name	City	State
United States	American Med Research Institute	Atlanta	Georgia
United States	Infectious Disease Rsch Consortium of GA / SE Clin Resources	Atlanta	Georgia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Illinois Masonic Med Ctr / The Cancer Ctr	Chicago	Illinois
United States	Northwestern Med Faculty Foundation	Chicago	Illinois
United States	Rush Presbyterian Med College	Chicago	Illinois
United States	Comprehensive Care Ctr	Dallas	Texas
United States	Henry Ford Hosp	Detroit	Michigan
United States	Hematology - Oncology Med Group of San Fernando Valley	Encino	California
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Immunological Institute	Houston	Texas
United States	Twelve Oaks Hosp	Houston	Texas
United States	Dr Becky Miller	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Mem Sloan - Kettering Cancer Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	New York Univ Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Saint Vincent's Hosp and Med Ctr	New York	New York
United States	Graduate Hosp / Tuttleman Cancer Ctr	Philadelphia	Pennsylvania
United States	Apogee Med Group	San Diego	California
United States	Kaiser Permanente Med Ctr	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	UCSF	San Francisco	California
United States	UCSF	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	Virginia Mason Research Center / Clinical Trial Unit	Seattle	Washington
United States	Pacific Oaks Med Group	Sherman Oaks	California
United States	Washington Univ	St. Louis	Missouri
United States	H Lee Moffit Cancer Ctr and Research Institute	Tampa	Florida
United States	Dr Mahmoud Mustafa	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sequus Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)