Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00526318|
Recruitment Status : Unknown
Verified July 2015 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 10, 2007
Last Update Posted : July 16, 2015
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.
PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: ifosfamide Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Drug: vindesine Procedure: autologous hematopoietic stem cell transplantation Radiation: iobenguane I 131 Radiation: radiation therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Official Title:||Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2016|
- Event-free survival (EFS)
- Overall survival (OS)
- Impact of well established clinical and molecular risk factors on EFS and OS
- Early response, measured after 2 courses of induction chemotherapy
- Response to induction therapy, measured before autologous stem cell transplantation
- Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy
- Impact of the extent of initial and best surgery on outcome and frequency of complications
- Acute and late toxicity of radiotherapy
- Correlation of MIBG activity with whole-body radiation dose
- Molecular markers (MYCN and status of chromosome 1p and 11q)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526318
|Study Chair:||Frank Berthold, MD||Children's Hospital Medical Center, Cincinnati|