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NCT00808899 · ClinicalTrials.gov registry record · Phase 2
Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT00808899: Clinical Trial Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT00808899 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00808899, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell transplantation. The first five courses of induction chemotherapy will also evaluate the feasibility of combining weekly temsirolimus with these standard chemotherapy combinations. This will be followed by 16 months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight months of oral topotecan.
Primary Outcome
The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Irinotecan
- DRUG Temsirolimus
- PROCEDURE Surgical Resection of Primary Tumor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
Why NCT00808899 stopped before completion
NCT00808899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00808899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00808899 about?
NCT00808899 is a clinical study titled "Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma". A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hema...
What is the current status of trial NCT00808899?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2008-12. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00808899?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Irinotecan (DRUG), Temsirolimus (DRUG), Surgical Resection of Primary Tumor (PROCEDURE).
Who is sponsoring clinical trial NCT00808899?
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 NCT00808899's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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