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NCT00718757 · ClinicalTrials.gov registry record · Phase 1

Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies

A Phase 1 study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
Phase 1
Development phase
4
Enrollment target

NCT00718757: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.

NCT00718757 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00718757, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
Phase 1
Development phase
4 participants
Enrollment target

Study Summary

The purpose of this study is to estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan (given IV, qd x 5, 2 days off, qd x 5) and vincristine (given IV, 2 doses total on days 1 and 8 of schedule) in children with relapsed or refractory hematologic malignancies. In addition we will also study the pharmacokinetics of irinotecan when given without and then with dexamethasone in each patient, evaluate the relationship between irinotecan pharmacokinetic parameters and toxicity and describe any antitumor effects.

Interventions

  • DRUG Dexamethasone
  • DRUG Vincristine
  • DRUG Irinotecan

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2005-01
Est. Completion 2009-01
Phase Phase 1

What the finished NCT00718757 record still lists

NCT00718757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.

NCT00718757 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00718757 about?

NCT00718757 is a clinical study titled "Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies". The purpose of this study is to estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan (given IV, qd x 5, 2 days off, qd x 5) and vincristine (given IV, 2 doses total on days 1 and 8 of schedule) in children with relapsed or ref...

What is the current status of trial NCT00718757?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2005-01. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00718757?

The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Irinotecan (DRUG).

Who is sponsoring clinical trial NCT00718757?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00718757's enrollment target sits among peer trials

4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00718757, the US trial registry maintained by the National Library of Medicine. NCT00718757 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.