A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
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| ClinicalTrials.gov Identifier: NCT00002319 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Sponsor:
Sequus Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sarcoma, Kaposi HIV Infections | Drug: Doxorubicin hydrochloride (liposomal) | Phase 3 |
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 (Clinical Trial) |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002319
Locations
Show 33 study locations
Sponsors and Collaborators
Sequus Pharmaceuticals
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)
| ClinicalTrials.gov Identifier: | NCT00002319 |
| Other Study ID Numbers: |
134C LTI-30-12 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | January 1996 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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Sarcoma, Kaposi Liposomes Doxorubicin Acquired Immunodeficiency Syndrome Drug Carriers |
Additional relevant MeSH terms:
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Sarcoma, Kaposi Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Virus Diseases Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue |
Doxorubicin Liposomal doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |