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NCT00000660 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00000660 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants.

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The verdict

NCT00000660, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for determining the effect of oral VP-16 on Kaposi's sarcoma. VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain, inconvenience, and potential complications associated with medications administered intravenously. The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug administration is the other focus of this study.

Interventions

  • DRUG Etoposide

Trial Details

FieldValue
Enrollment Target 24 participants
Est. Completion 1992-07
Phase Phase 1

What the Registry Record Tells You About NCT00000660

The ClinicalTrials.gov registry entry for NCT00000660 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Etoposide is the first listed.

NCT00000660 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000660 about?

NCT00000660 is a clinical study titled "Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma". To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for determining the effect of o...

What is the current status of trial NCT00000660?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. Estimated completion is 1992-07.

What interventions are being tested in trial NCT00000660?

The interventions under investigation include: Etoposide (DRUG).

Who is sponsoring clinical trial NCT00000660?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.