Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

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 provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

Detailed Description

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Patients receive DOX-SL every 3 weeks for up to 20 cycles.

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

Patients must have:

* AIDS-related Kaposi's sarcoma that requires systemic chemotherapy.
* EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL.

Prior Medication:

Allowed:

* Prior anthracyclines.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Cardiac ejection fraction \< 50 percent or clinically significant cardiac disease.
* Eligibility for a Liposomal Technology comparative protocol.

Concurrent Medication:

Excluded:

* Other cytotoxic chemotherapy.

Patients with the following prior condition are excluded:

History of idiosyncratic or allergic reaction to anthracyclines.

Prior Medication:

Excluded:

* Chemotherapy within the past 3 weeks.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Sequus Pharmaceutical Inc

Menlo Park, California, 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-30-25

Identifier Type: -

Identifier Source: secondary_id

134D