Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003207
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
1999-11-01
Brief Title:
Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposis Sarcoma or Other Advanced Cancers
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Phase I Study on Doxil and SDZ PSC 833 in the Treatment of AIDS-Associated Kaposis Sarcoma and Other Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-04
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:
The rationale for conducting this study lies in the premise that if indeed the reason for a limited response of Kaposis sarcoma lesions and other advanced malignancies to chemotherapy is attributable to a high expression of P-glycoprotein then by inhibiting this pump tumor kill would be enhanced and response rates as well as duration of responses would also increase Doxil is chosen since recent studies have shown that it is superior to combination chemotherapy with ABV or BV Doxil is also known to be active in other malignancies such as breast and ovarian cancer 3435 PSC 833 is chosen since it has been found to reverse P-gp in vitro and in vivo is non-immunosuppressive and has been shown in recent Phase 1 studies to be well tolerated
There are yet no human studies reported on Doxil pharmacokinetics when combined with MDR modulators Preclinical data shows that pharmacokinetics of Doxil unlike free doxorubicin is minimally affected by the addition of PSC 833 36 Enhanced tumor toxicity was observed when PSC 833 was combined with Doxil Since doxorubicin the active agent in Doxil is metabolized by the same cytochrome P450 interactions between these 2 agents may have very significant clinical implications The purpose of this study is to assess the toxicity and determine the maximum tolerated dose of Doxil when combined with PSC 833 in the treatment of AIDS-KS and other advanced malignancies
There are yet no human studies reported on Doxil pharmacokinetics when combined with MDR modulators Preclinical data shows that pharmacokinetics of Doxil unlike free doxorubicin is minimally affected by the addition of PSC 833 36 Enhanced tumor toxicity was observed when PSC 833 was combined with Doxil Since doxorubicin the active agent in Doxil is metabolized by the same cytochrome P450 interactions between these 2 agents may have very significant clinical implications The purpose of this study is to assess the toxicity and determine the maximum tolerated dose of Doxil when combined with PSC 833 in the treatment of AIDS-KS and other advanced malignancies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T97-0073 | None | None | None |
| WU-106 | None | None | None |