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NCT00135135 · ClinicalTrials.gov registry record · Phase 2
Therapy for Children With Neuroblastoma
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00135135: Completed Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT00135135 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135135, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan window will be efficacious.
Interventions
- DRUG Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid
- PROCEDURE Radiation therapy, Surgery, Peripheral Stem cell transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2005-08 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
What the finished NCT00135135 record still lists
NCT00135135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid is the first listed.
NCT00135135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135135 about?
NCT00135135 is a clinical study titled "Therapy for Children With Neuroblastoma". This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotec...
What is the current status of trial NCT00135135?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2005-08. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00135135?
The interventions under investigation include: Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid (DRUG), Radiation therapy, Surgery, Peripheral Stem cell transplant (PROCEDURE).
Who is sponsoring clinical trial NCT00135135?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135135's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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