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NCT00001570 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
A Phase 1 study of Neoplasm Metastasis and Kidney Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT00001570 is a Phase 1 study of Neoplasm Metastasis and Kidney Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 415-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001570, a Phase 1 study of Neoplasm Metastasis and Kidney Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a second for 6 days, before the first cohort is enrolled. Vinblastine is administered in escalating doses on days 2-5. At least 3 patients are entered at each dose level. The MTD will be defined as the dose immediately below that at which 2 patients experience dose limiting toxicity. Treatment continues every 28 days.
Conditions Studied
Interventions
- DRUG vinblastine
- DRUG PSC 833
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 1997-02 |
| Est. Completion | 2001-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001570
The ClinicalTrials.gov registry entry for NCT00001570 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 415-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 2 interventions - of which vinblastine is the first listed.
NCT00001570 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001570 about?
NCT00001570 is a clinical study titled "A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer". Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a second for 6 days, befor...
What is the current status of trial NCT00001570?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 1997-02. Estimated completion is 2001-01.
What conditions does trial NCT00001570 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Kidney Neoplasms.
What interventions are being tested in trial NCT00001570?
The interventions under investigation include: vinblastine (DRUG), PSC 833 (DRUG).
Who is sponsoring clinical trial NCT00001570?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001570 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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