COG: ANBL12P1 Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High Risk Neuroblastoma: A Groupwide Pilot Study

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COG: ANBL12P1 Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High Risk Neuroblastoma: A Groupwide Pilot Study

1.To determine if the acute toxicity of an autologous stem cell transplant with a busulfan/melphalan (BuMel) based regimen is tolerable when given as
Consolidation therapy for high-risk neuroblastoma.

2.To determine the incidence of non-hematologic organ toxicity (Grade 3 and higher) and all causes of mortality in patients undergoing autologous stem cell transplant with a BuMel based regimen followed by local radiotherapy for the treatment of high-risk neuroblastoma.

3. To describe response rates, event-free survival (EFS), and overall survival (OS) for patients undergoing Induction therapy followed by Consolidation with myeloablative BuMel preparative regimen and local radiotherapy for the treatment of high-risk neuroblastoma.

4.To correlate busulfan pharmacokinetics with non-
hematologic toxicity following a BuMel based autologous transplant regimen
and event-free survival and overall survival

5.To determine the feasibility of performing Curie scores in real time, as assessed by central scan committee review of a 123 I-MIBG scan obtained after Cycle 4 of Induction therapy.

6. To examine the concordance between central reviewers and institutional reviewers in performing Curie scoring at diagnosis and after Cycle 4 of Induction therapy.

7. To determine the feasibility of detecting aberrations in the Anaplastic Lymphoma Kinase (ALK)gene in tumors obtained at the time of diagnosis in patients with high-risk neuroblastoma.

8.To determine the feasibility of performing molecular profiling of neuroblastoma tumors obtained at the time of diagnosis in patients with high
-risk neuroblastoma.

9. To correlate melphalan pharmacokinetics with non-hematologic toxicity following a BuMelbased autologous transplant regimenand event-
free survival and overall survival

Protocol Number111304
Principal InvestigatorRichard Drachtman
PhasePilot
ScopeNational
Applicable Disease SitesAny Site
Therapies InvolvedChemotherapy multiple agents systemic
Radiotherapy
Drugs InvolvedDOXORUBICIN
CYCLOPHOSPHAMIDE
VINCRISTINE
BUSULFAN
ETOPOSIDE
MELPHALAN
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.