Clinical trial NCT00002319: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Sarcoma, Kaposi
Liposomes
Doxorubicin
Acquired Immunodeficiency Syndrome
Drug Carriers
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

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