RecruitingPhase 2NCT02605421

Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

12 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a two-stage (tandem) stem cell transplant approach — using the patient's own stem cells — as a consolidation treatment for children and young adults with high-risk neuroblastoma who have completed their initial chemotherapy. **You may be eligible if...** - You are under 30 years old at the time of neuroblastoma diagnosis - You have completed your initial chemotherapy (induction) and your disease has shown at least some response (complete response, partial response, minor response, or stable disease) - Your blood counts have recovered from the last cycle of chemotherapy - You have no uncontrolled infections - Sufficient stem cells have been collected and stored for both transplants - Your heart, lung, liver, and kidney functions all meet the required levels - You or your parent/guardian can provide written consent **You may NOT be eligible if...** - You do not have adequate stem cells stored for transplantation - Your organ function does not meet the minimum required levels - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.

BIOLOGICALGranulocyte colony stimulating factor

Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF SQ or IV (SQ preferred) 5 micrograms/kg once daily and continuing once daily until post-nadir ANC \> 2000/μL for 3 consecutive days.


Locations(1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

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NCT02605421


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