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RECRUITING
NCT02605421
PHASE2

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

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 30 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2016-06

Completion Date

2026-12

Last Updated

2025-10-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

Thiotepa

Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.

DRUG

Cyclophosphamide

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.

DRUG

Melphalan

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.

DRUG

Etoposide

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.

DRUG

Carboplatin

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.

BIOLOGICAL

Autologous Stem Cell Infusion

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

BIOLOGICAL

Granulocyte 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