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

NCT ID: NCT00002319

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Sarcoma, Kaposi HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Doxorubicin hydrochloride (liposomal)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sequus Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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East Bay AIDS Ctr

Berkeley, California, United States

Site Status

Pacific Oaks Med Group

Beverly Hills, California, United States

Site Status

Hematology - Oncology Med Group of San Fernando Valley

Encino, California, United States

Site Status

Dr Becky Miller

Los Angeles, California, United States

Site Status

Apogee Med Group

San Diego, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Kaiser Permanente Med Ctr

San Francisco, California, United States

Site Status

UCSF

San Francisco, California, United States

Site Status

San Francisco Veterans Administration Med Ctr

San Francisco, California, United States

Site Status

UCSF

San Francisco, California, United States

Site Status

Pacific Oaks Med Group

Sherman Oaks, California, United States

Site Status

Dr Mahmoud Mustafa

Washington D.C., District of Columbia, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

H Lee Moffit Cancer Ctr and Research Institute

Tampa, Florida, United States

Site Status

American Med Research Institute

Atlanta, Georgia, United States

Site Status

Infectious Disease Rsch Consortium of GA / SE Clin Resources

Atlanta, Georgia, United States

Site Status

Northwestern Med Faculty Foundation

Chicago, Illinois, United States

Site Status

Rush Presbyterian Med College

Chicago, Illinois, United States

Site Status

Illinois Masonic Med Ctr / The Cancer Ctr

Chicago, Illinois, United States

Site Status

Henry Ford Hosp

Detroit, Michigan, United States

Site Status

Washington Univ

St Louis, Missouri, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Saint Vincent's Hosp and Med Ctr

New York, New York, United States

Site Status

New York Univ Med Ctr

New York, New York, United States

Site Status

Mem Sloan - Kettering Cancer Ctr

New York, New York, United States

Site Status

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

Site Status

Mount Sinai Med Ctr

New York, New York, United States

Site Status

Graduate Hosp / Tuttleman Cancer Ctr

Philadelphia, Pennsylvania, United States

Site Status

Comprehensive Care Ctr

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Houston Immunological Institute

Houston, Texas, United States

Site Status

Twelve Oaks Hosp

Houston, Texas, United States

Site Status

Virginia Mason Research Center / Clinical Trial Unit

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

Other Identifiers

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LTI-30-12

Identifier Type: -

Identifier Source: secondary_id

134C

Identifier Type: -

Identifier Source: org_study_id