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NCT00311584 · ClinicalTrials.gov registry record · Phase 2
Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00311584: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT00311584 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00311584, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma.
Primary Outcome
The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as "best response". Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (
Interventions
- DRUG temozolomide
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2006-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00311584 record still lists
NCT00311584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which temozolomide is the first listed.
NCT00311584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00311584 about?
NCT00311584 is a clinical study titled "Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma". RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II...
What is the current status of trial NCT00311584?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2006-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00311584?
The interventions under investigation include: temozolomide (DRUG), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00311584?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00311584's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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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