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NCT02786719 · ClinicalTrials.gov registry record · NA
High-Risk Neuroblastoma Chemotherapy Without G-CSF
A NA study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT02786719 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 13 participants.
The verdict
NCT02786719, a NA study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
Patients will be asked to participate in this study because patients have been diagnosed with high-risk neuroblastoma, a common childhood cancer which has aggressive features. If left untreated, high-risk neuroblastoma is fatal. Children with high-risk neuroblastoma often respond to current available treatments, but there is a high risk that the cancer will return. This study will test the safety of giving standard induction treatment for high-risk neuroblastoma without one of the drugs commonly used to prevent side effects. Current treatment for high-risk neuroblastoma includes anti-cancer drugs (chemotherapy), surgery, radiation therapy and high-dose chemotherapy with hematopoietic stem cell rescue. Treatment takes about one year to complete and occurs in 3 phases: induction, consolidation, and maintenance. This study is limited to the induction phase of treatment. Induction therapy includes six chemotherapy drugs given in different combinations every 3 weeks for a total of 6 courses. For the past decade, induction chemotherapy has been followed by a drug called granulocyte colony stimulating factor (G-CSF, filgrastim, peg-filgrastim, Neupogen, or Neulasta) to prevent side effects from the chemotherapy. G-CSF is routinely given to patients with high risk neuroblastoma after chemotherapy to stimulate white blood cell production and shorten the time period when the absolute neutrophil count (ANC), a type of white blood cell, is low after chemotherapy. G-CSF is known to shorten the period of low ANC by approximately 3 days. When the ANC is lowest, a patient is most at risk of getting a bacterial infection. Recent lab experiments in mice have shown that neuroblastoma tumor cells may respond to G-CSF by growing faster and metastasizing (spreading to other parts of the body). There have been no clinical trials comparing the survival of children with high risk neuroblastoma with or without G-CSF. This clinical trial is the first step towards giving induction chemother
Interventions
- DRUG Cyclophosphamide
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Vincristine
- DRUG Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-02-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02786719
The ClinicalTrials.gov registry entry for NCT02786719 describes a study currently listed as completed, categorized as NA. 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.
NCT02786719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02786719 about?
NCT02786719 is a clinical study titled "High-Risk Neuroblastoma Chemotherapy Without G-CSF". Patients will be asked to participate in this study because patients have been diagnosed with high-risk neuroblastoma, a common childhood cancer which has aggressive features. If left untreated, high-risk neuroblastoma is fatal. Children with high-risk neuroblastoma often respond to current availabl...
What is the current status of trial NCT02786719?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2016-06. Estimated completion is 2019-02-05.
What interventions are being tested in trial NCT02786719?
The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Vincristine (DRUG), Topotecan (DRUG).
Who is sponsoring clinical trial NCT02786719?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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