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

ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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/Vaccine

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

  • Granulocyte colony stimulating factor

    Biological/Vaccine

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Patients Treated for NeuroblastomaExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival

Percentage of patients with progression free survial. Kaplan-Meier curves and 95% confidence intervals will be used to estimate.

Time frame
3 years from first PBSC infusion

Secondary outcomes

1

Time to Engraftment

Defined as an absolute neutrophil count (ANC) greater than or equal to 0.5 x 109/L for three consecutive days by day 42 after first transplant.

Time frame
Day 42
2

Relapse

Percentage of patients with relapse. Relapse will be defined as any new lesion; increase of any measurable lesion by \>25%; previous negative bone is positive.

Time frame
3 years from first PBSC infusion
3

Overall Survival

Kaplan-Meier curves and 95% confidence intervals will be used to estimate overall survival.

Time frame
3 years from first PBSC infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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