Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002319
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of DOX-SL in the Treatment of AIDS-Related Kaposis Sarcoma
Sponsor:
Sequus Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Open Trial of DOX-SL Stealth Liposomal Doxorubicin Hydrochloride in the Treatment of Moderate to Severe AIDS-Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
1996-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride DOX-SL in the long-term treatment of AIDS-related Kaposis 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 Kaposis sarcoma therapy because of inadequate efficacy or unacceptable toxicity To provide a defined protocol for Kaposis sarcoma patients for whom DOX-SL therapy is indicated
Detailed Description:
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LTI-30-12 | None | None | None |