Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
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...
Brief Summary
Official Title: “Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
Detailed Clinical Trial Description
Patients receive DOX-SL every 3 weeks for up to 20 cycles.
Intervention(s) in this Clinical Trial
- Drug: Doxorubicin hydrochloride (liposomal)
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sequus Pharmaceuticals Industry
Related Publications
References
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)
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002147
Study ID Number: 134D
ClinicalTrials.gov Identifier: NCT00002147
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00002147
