Current Research: Pediatric Hematology-Oncology

ANBL0531 --  Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy with or without isotretinoin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating young patients with neuroblastoma.

This phase III trial is comparing different regimens of combination chemotherapy and surgery with or without isotretinoin to see how well they work in treating young patients with neuroblastoma.

Eligibility

Patients may be eligible for this trial if:

• Less than 12 years of age at the time of initial diagnosis
• Enrollment on ANBL00B1 is required for all newly diagnosed patients within 21 days of the definitive diagnostic procedure, with the exception of infants with stage 4S neuroblastoma who are too ill to undergo a diagnostic biopsy procedure.
• Submission of the EDTA blood sample listed in ANBL00B1 is REQUIRED in order for the patient to be eligible for therapy reduction.
• Patients without symptoms may be enrolled and treated immediately with chemotherapy at the discretion of the investigator if it is considered to be in the best interest of the patient (e.g., a patient with intradural tumor extension who is at risk of developing neurologic deficits).
• No prior chemotherapy is allowed before initiating protocol therapy with the following exception: Patients who required emergency therapy, either prior to the biopsy or before biology markers are available, can be given chemotherapy prior to the biopsy, as long as the biopsy is subsequently performed within 96 hours and all other eligibility criteria are met. For the purposes of this study, dexamethasone will not be considered chemotherapy and may be administered prior to initiating protocol therapy.

Trial Sponsor

• Children’s Oncology Group (COG)

Project Begin Date

• Feb 2008

Tentative Project End Date

• Sept 2012

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .