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NCT00578864 · ClinicalTrials.gov registry record · Phase 2
Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma
A Phase 2 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00578864 is a Phase 2 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 13 participants.
The verdict
NCT00578864, a Phase 2 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
High-risk neuroblastoma is an aggressive childhood cancer that shows up as a lump or mass in the belly or around the spinal cord in the chest, neck, or pelvis. Often the tumor has spread around the body to the bones or to the soft center of the bone, called the bone marrow. High-risk neuroblastoma often responds to treatment at first, but it frequently comes back and may be even more difficult to treat. Chemotherapy (drug treatments for cancer) is usually given at high doses in short bursts (3 to 5 days) followed by a few weeks of rest and recovery. This burst and recovery is called a "cycle" and usually takes about 21 days. Some scientists and physicians have tried to give chemotherapy at lower doses for more days, called "metronomic" chemotherapy. This method of giving chemotherapy has been used to treat neuroblastoma that has failed more standard types of treatment (relapsed neuroblastoma) and has shown some promise for those patients. One of the reasons it may work is by killing the blood vessels that feed the tumor as well as killing tumor cells themselves (the way that burst chemotherapy works). We think that giving a burst of chemotherapy together with metronomic therapy may kill the tumor while decreasing the side effects that we have seen in the past. Treatment for high risk neuroblastoma usually occurs in 3 stages: induction, consolidation, and maintenance. During the induction phase, patients will receive chemotherapy and possibly more surgery to get rid of most of the tumor cells. Most of the chemotherapy drugs during induction will be given in the standard burst method. One of the chemotherapy drugs, etoposide, will be given in lower, metronomic doses. The doctors will study how the tumors respond and the side effects patients have. After induction most childrens' tumors will have disappeared, also called remission. These children will receive the second stage of treatment called consolidation. During this stage, subjects will receive radiation treatm
Interventions
- DRUG Cyclophosphamide
- DRUG Cisplatin
- DRUG Doxorubicin
- DRUG Protracted Oral Etoposide
- DRUG IV Bolus Etoposide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2007-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578864
The ClinicalTrials.gov registry entry for NCT00578864 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00578864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00578864 about?
NCT00578864 is a clinical study titled "Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma". High-risk neuroblastoma is an aggressive childhood cancer that shows up as a lump or mass in the belly or around the spinal cord in the chest, neck, or pelvis. Often the tumor has spread around the body to the bones or to the soft center of the bone, called the bone marrow. High-risk neuroblastoma o...
What is the current status of trial NCT00578864?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2007-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT00578864?
The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Doxorubicin (DRUG), Protracted Oral Etoposide (DRUG), IV Bolus Etoposide (DRUG).
Who is sponsoring clinical trial NCT00578864?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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