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Protocol No. 2015LS108 Principal Investigator Stefanski, Heather
Phase Phase II
Age Group Children Scope Local
Secondary Protocol No. MT2015-25C
Title MT2015-25C : Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Objective Primary Objective: To evaluate 3 year progression free survival (PFS) rate of high-risk neuroblastoma patients after treatment with a tandem consolidation of Thiotepa/Cyclophosphamide and PBSC rescue followed by Carboplatin/Etoposide/ Melphalan (CEM) and PBSC rescue, as compared to historical controls of a single CEM consolidation course with PBSC rescue. Secondary Objectives: To determine key transplant outcomes as tracked by the departmental BMT database including time to engraftment, relapse, and overall survival.
Treatment Intravenous Administration of Thiotepa, Cyclophosphamide, Mesna, Melphalan, Etoposide, Carboplatin and Infusion of mobilized stem cells.
Description This is a phase II single center study to administer two courses of myeloablative consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC) rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy (independent of this study). Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended to begin consolidation within 4-6 weeks after the start of Induction Cycle #5. Consolidation course #1 consists of thiotepa and cyclophosphamide followed by a PBSC rescue. Six to 10 weeks from day 0 (rescue), consolidation course #2, consisting of melphalan, etoposide and carboplatin, is initiated followed by a 2nd PBSC rescue. It is estimated that a total of 12 patients will be enrolled in this study.
Key Eligibility No evidence of disease progression: defined as increase in tumor size of >25% or new lesions • Hematopoietic recovery from last induction course of chemotherapy (ANC 500 and platelets >20K). • No uncontrolled infection • Minimum frozen PBSCs of • Minimum frozen PBSCs of 2 x 10^6 CD34 cells/kg for each transplant are mandatory and a PBSC of 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of no less than 6 x 10^6 CD34 cells/kg is encouraged). These must be collected prior to starting consolidation. CD34 cells/kg for each transplant are mandatory and a PBSC of 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of no less than 6 x 10^6 CD34 cells/kg is encouraged). These must be collected prior to starting consolidation. • Adequate organ function defined as: Hepatic: AST < 3 x upper limit of institutional normal Cardiac: shortening fraction &#8805; 27% or ejection fraction &#8805; 50%, no clinical congestive heart failure Renal: creatinine clearance or GFR > 60 mL/min/1.73m^2 (If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2 )
Applicable Disease Sites Brain and Nervous System
Other Endocrine System
Therapies Involved Blood and Marrow Transplant
Drugs Involved CARBOPLATIN (PARAPLATIN)
CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
ETOPOSIDE (VP-16)
MELPHALAN (ALKERAN)
THIOTEPA
Status Open
Participating Institutions Masonic Cancer Center
Treatment Type Treatment
Contact Kim Nelson Phone:
Email:knelso062@fairview.org