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NCT00017368 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT00017368: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT00017368 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00017368, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 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. Combining more than one drug may kill more tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed neuroblastoma.
Primary Outcome
The endpoint used for early stopping rule 9.51 will be transplant-related mortality (TRM). A TRM is defined as any death occurring within 30 days after either the first or second HDC/SCR. The acceptable TRM rate is 7.5%. This rate is based on TRM rates previously observed in the prior CCG study 594, CCG study 3891, and POG study 9640 of 7%, 6%, and 0%, respectively.
Interventions
- DRUG cisplatin
- DRUG carboplatin
- DRUG cyclophosphamide
- BIOLOGICAL filgrastim
- BIOLOGICAL sargramostim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2001-04 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT00017368 record still lists
NCT00017368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00017368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00017368 about?
NCT00017368 is a clinical study titled "Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cel...
What is the current status of trial NCT00017368?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2001-04. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00017368?
The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), cyclophosphamide (DRUG), filgrastim (BIOLOGICAL), sargramostim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00017368?
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 NCT00017368's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 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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