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NCT00253435 · ClinicalTrials.gov registry record · Phase 2
N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
A Phase 2 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00253435 is a Phase 2 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 50 participants.
The verdict
NCT00253435, a Phase 2 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed. Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma.
Interventions
- DRUG Melphalan
- DRUG Carboplatin
- DRUG Etoposide
- BIOLOGICAL Filgrastim
- PROCEDURE Peripheral blood stem cell infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00253435
The ClinicalTrials.gov registry entry for NCT00253435 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT00253435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00253435 about?
NCT00253435 is a clinical study titled "N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma". RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing th...
What is the current status of trial NCT00253435?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2005-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00253435?
The interventions under investigation include: Melphalan (DRUG), Carboplatin (DRUG), Etoposide (DRUG), Filgrastim (BIOLOGICAL), Peripheral blood stem cell infusion (PROCEDURE).
Who is sponsoring clinical trial NCT00253435?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
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