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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT02605421
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Thiotepa — DRUG
    Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.
  • Cyclophosphamide — DRUG
    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.
  • Melphalan — DRUG
    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.
  • Etoposide — DRUG
    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.
  • Carboplatin — DRUG
    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.
  • Autologous Stem Cell Infusion — BIOLOGICAL
    On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
  • Granulocyte colony stimulating factor — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2016
Status verified
Oct 2025
Primary completion
Oct 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients Treated for Neuroblastoma
    Consolidation course #1 consists of thiotepa and cyclophosphamide followed by a PBSC rescue. Consolidation course #2 consists of melphalan, etoposide and carboplatin followed by a second PBSC rescue. Post infusion, patients will receive Granulocyte-Colony Stimulating Factor beginning on Day 0 of each consolidation course.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 3 years from first PBSC infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455
Lisa Burke, RN
[email protected]
612-273-8482
Ashish Gupta, MBBS, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MN

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