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NCT00003207 · ClinicalTrials.gov registry record · Phase 1
Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00003207 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 14 participants.
The verdict
NCT00003207, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The rationale for conducting this study lies in the premise that if indeed the reason for a limited response of Kaposi's 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 (34,35). 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.
Interventions
- DRUG pegylated liposomal doxorubicin hydrochloride
- DRUG PSC 833
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 1998-03 |
| Est. Completion | 2002-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00003207
The ClinicalTrials.gov registry entry for NCT00003207 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which pegylated liposomal doxorubicin hydrochloride is the first listed.
NCT00003207 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00003207 about?
NCT00003207 is a clinical study titled "Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers". The rationale for conducting this study lies in the premise that if indeed the reason for a limited response of Kaposi's 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...
What is the current status of trial NCT00003207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 1998-03. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00003207?
The interventions under investigation include: pegylated liposomal doxorubicin hydrochloride (DRUG), PSC 833 (DRUG).
Who is sponsoring clinical trial NCT00003207?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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