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NCT00078988 · ClinicalTrials.gov registry record · Phase 3
High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT00078988: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00078988 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078988, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Isotretinoin may be effective in preventing recurrence of glioma. It is not yet known which regimen of chemotherapy plus autologous stem cell transplantation with or without isotretinoin is more effective in treating recurrent high-grade glioma. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation to see how well it works compared to high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation and isotretinoin in treating young patients with recurrent high-grade glioma.
Primary Outcome
The primary endpoint for the evaluation of treatment efficacy will be event-free survival (EFS)
Interventions
- DRUG carboplatin
- DRUG etoposide
- BIOLOGICAL filgrastim
- DRUG thiotepa
- DRUG isotretinoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2004-10 |
| Est. Completion | 2006-09 |
| Phase | Phase 3 |
What the finished NCT00078988 record still lists
NCT00078988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT00078988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00078988 about?
NCT00078988 is a clinical study titled "High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas". RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs ...
What is the current status of trial NCT00078988?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2004-10. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00078988?
The interventions under investigation include: carboplatin (DRUG), etoposide (DRUG), filgrastim (BIOLOGICAL), thiotepa (DRUG), isotretinoin (DRUG).
Who is sponsoring clinical trial NCT00078988?
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 NCT00078988's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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