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NCT00001335 · ClinicalTrials.gov registry record · Phase 2
New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma
A Phase 2 study of Neuroblastoma and Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT00001335: Completed Phase 2 study of Neuroblastoma and Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).
NCT00001335 is a Phase 2 study of Neuroblastoma and Rhabdomyosarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 90 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001335, a Phase 2 study of Neuroblastoma and Rhabdomyosarcoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF), rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term disease-free survival. Though less grave, the prognosis for cure for other high-risk patients is approximately 50%. New treatment strategies, including the identification of highly active new agents, maximizing the dose intensity of the most active standard drugs, and the development of improved methods of consolidation to eradicate microscopic residual disease, are clearly needed to improve the outcome of these patients. This protocol will address these issues by commencing with a Phase II window, for the highest risk patients, to evaluate a series of promising drugs with novel mechanisms of action. All patients will then receive 5 cycles of dose-intensive "best standard therapy" with doxorubicin (adriamycin), vincristine, and cyclophosphamide (VAdriaC). Patients at high risk of relapse will continue onto a phase I consolidation regimen consisting of three cycles of dose-escalated Melphalan, Ifosfamide, Mesna, and Etoposide (MIME). Peripheral blood stem cell transfusions (PBSCT) and recombinant human G-CSF will be used as supportive care measures to allow maximal dose-escalation of this combination regimen.
Conditions Studied
Interventions
- DRUG G-CSF
- DRUG Topotecan
- DRUG ADR-529
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 1993-04 |
| Est. Completion | 2002-01 |
| Phase | Phase 2 |
What the finished NCT00001335 record still lists
NCT00001335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 3 interventions - of which G-CSF is the first listed.
NCT00001335 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001335 about?
NCT00001335 is a clinical study titled "New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma". The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF), rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term disease-free survival. Though less grave, the prognosis for cure for other high-risk patients is approximately 50%. New trea...
What is the current status of trial NCT00001335?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 1993-04. Estimated completion is 2002-01.
What conditions does trial NCT00001335 study?
This clinical trial studies the following conditions: Neuroblastoma, Rhabdomyosarcoma, Ewing's Sarcoma.
What interventions are being tested in trial NCT00001335?
The interventions under investigation include: G-CSF (DRUG), Topotecan (DRUG), ADR-529 (DRUG).
Who is sponsoring clinical trial NCT00001335?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001335 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001335's enrollment target sits among peer trials
90 34th of 94 higher than 60 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma 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.
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