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

Phase 3
18 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

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

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- 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


- 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:


- 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.

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Liposomes
  • Doxorubicin
  • Acquired Immunodeficiency Syndrome
  • Drug Carriers
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



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