Combination Chemotherapy in Treating Children With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00003093|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 1, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma.
PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 3|
- Determine whether the use of selected prognostic variables to assign treatment increases the event-free survival and overall survival in children with intermediate-risk neuroblastoma.
- Determine the acute and long-term morbidity and toxicity of surgery and combination chemotherapy in this patient population.
- Assess the relationship between extent of tumor resection and event-free and overall survival in patients treated with this regimen.
OUTLINE: Patients receive carboplatin IV over 1 hour on days 0, 21, and 63; cyclophosphamide IV over 1 hour on days 21 and 42; doxorubicin IV over 15-60 minutes on days 21 and 63; and etoposide IV over 2 hours on days 0-2, 42-44, and 63-65. Patients under 60 days of age also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after the last chemotherapy administration and continuing until blood counts recover. Patients with favorable biology who do not achieve complete remission then undergo surgery to remove or debulk residual disease on day 84 or when blood counts recover. Patients with favorable biology who achieve partial response and surgery to the primary site is not deemed in the best interest of the patient may receive additional chemotherapy (as below) and delay surgery to the primary site after completion of chemotherapy.
Patients with unfavorable biology receive additional chemotherapy comprising cyclophosphamide IV over 1 hour on days 84, 105, and 147; etoposide IV over 2 hours on days 84-86 and 126-128; carboplatin IV over 1 hour on days 105 and 126; and doxorubicin IV over 15-60 minutes on days 105 and 147. Patients then undergo debulking surgery on day 168 or when blood counts recover.
Some patients may then undergo radiotherapy after surgery.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||573 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study|
|Study Start Date :||March 1988|
|Primary Completion Date :||September 2006|
|Study Completion Date :||January 2011|
See detailed description.
Other Names:Biological: sargramostim
Other Names:Drug: carboplatin
Other Names:Drug: cyclophosphamide
Other Names:Drug: doxorubicin hydrochloride
Other Names:Drug: etoposide
Other Names:Procedure: conventional surgery Procedure: neoadjuvant therapy
- Event Free Survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003093
Show 235 Study Locations
|Study Chair:||David L. Baker, MD, MBBS, FRACP, FRCPA||Princess Margaret Hospital for Children|