Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Masonic Cancer Center, University of Minnesota
Summary
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.
Eligibility
- Age range
- Up to 30 years
- Sex
- All
- Healthy volunteers
- No
* Less than 30 years of age at diagnosis of neuroblastoma * End of Induction disease evaluation demonstrating CR, PR, MR or SD * Hematopoietic Recovery from last induction course of chemotherapy * No uncontrolled infection * 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 all be collected prior to the initiation of consolidation. * Adequate organ function defined as: * Hepatic: AST and ALT \< 3 x upper lim…
Interventions
- DrugThiotepa
Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.
- DrugCyclophosphamide
Cyclophosphamide by IV once daily for 4 doses on Days -5, -4, -3 and -2. Given as part of Consolidation Course #1 along with Thiotepa.
- DrugMelphalan
Melphalan by IV once daily for 3 doses on Days -8, -7, and -6. Given as part of Consolidation Course #2 along with Etoposide and Carboplatin.
- DrugEtoposide
Etoposide by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Melphalan and Carboplatin.
- DrugCarboplatin
Carboplatin by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Etoposide and Melphalan.
- BiologicalAutologous Stem Cell Infusion
Location
- Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota