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NCT00004068 · ClinicalTrials.gov registry record · Phase 2

Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor

A Phase 2 study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT00004068: Completed Phase 2 study, sponsored by St. Jude Children's Research Hospital.

NCT00004068 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004068, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain tumor.

Interventions

  • DRUG temozolomide
  • PROCEDURE conventional surgery
  • RADIATION radiation therapy
  • DRUG irinotecan hydrochloride

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 1999-03
Est. Completion 2003-04
Phase Phase 2

What the finished NCT00004068 record still lists

NCT00004068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 4 interventions - of which temozolomide is the first listed.

NCT00004068 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004068 about?

NCT00004068 is a clinical study titled "Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effe...

What is the current status of trial NCT00004068?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 1999-03. Estimated completion is 2003-04.

What interventions are being tested in trial NCT00004068?

The interventions under investigation include: temozolomide (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), irinotecan hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00004068?

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 NCT00004068's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00004068, the US trial registry maintained by the National Library of Medicine. NCT00004068 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.