NCT02605421 Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
| NCT ID | NCT02605421 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2016-06 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2016-06 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
* 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 limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, \> 1.0 1.5 x baseline if baseline was abnormal * Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure * Pulmonary: no evidence of dyspnea at rest and norequirement for supplemental oxygen * Renal: Creatinine clearance or GFR \> 60 mL/min/1.73m\^2. If a creatinine clearance is performed at end induction and the result is \< 100 ml/min/1.73m\^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of \< 100 ml/min/1.73m\^2 * Recovery from acute toxicities of last cycle of induction chemotherapy * Appropriate written consent - adult or parent/guardian if patient is \< 18 years of age and minor information sheet if patient is \> 8 years of age
Contact & Investigator
Ashish Gupta, MBBS, MPH
PRINCIPAL INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Frequently Asked Questions
Who can join the NCT02605421 clinical trial?
This trial is open to participants of all sexes, up to 30 Years, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02605421 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02605421 currently recruiting?
Yes, NCT02605421 is actively recruiting participants. Contact the research team at lburke3@Fairview.org for enrollment information.
Where is the NCT02605421 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT02605421 clinical trial?
NCT02605421 is sponsored by Masonic Cancer Center, University of Minnesota. The principal investigator is Ashish Gupta, MBBS, MPH at Masonic Cancer Center, University of Minnesota. The trial plans to enroll 12 participants.