Myeloablative chemotherapy and stem cell rescue for high-risk neuroblastoma
Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
This study is testing a new chemotherapy approach followed by a stem cell rescue to see if it helps children with high-risk neuroblastoma after their initial treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT02605421 on ClinicalTrials.gov |
What this trial studies
This phase II interventional study focuses on administering two courses of myeloablative consolidation chemotherapy followed by autologous peripheral blood stem cell rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy. The treatment aims to begin consolidation chemotherapy within 4-6 weeks after the fifth induction cycle. The study is conducted at a single center, the Masonic Cancer Center at the University of Minnesota, and involves specific eligibility criteria related to age, disease status, and organ function.
Who should consider this trial
Good fit: Ideal candidates are patients under 30 years of age diagnosed with high-risk neuroblastoma who have shown a positive response to prior induction chemotherapy.
Not a fit: Patients with uncontrolled infections or those who do not meet the organ function criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and outcomes for patients with high-risk neuroblastoma.
How similar studies have performed: Other studies have shown promise with similar myeloablative approaches in treating high-risk neuroblastoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ashish Gupta, MBBS, MPH — Masonic Cancer Center, University of Minnesota
- Study coordinator: Lisa Burke
- Email: lburke3@Fairview.org
- Phone: 612-273-8482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.