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

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Nov 12, 2015

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment approach for children and young adults with high-risk neuroblastoma, a type of cancer that affects the nervous system. The study involves giving two rounds of strong chemotherapy, known as myeloablative consolidation therapy, followed by a procedure that uses the patient’s own stem cells to help recover from the effects of the treatment. This is important because it can help the body recover while also targeting any remaining cancer cells after initial treatment.

To participate in this trial, patients must be under 30 years old at the time of their neuroblastoma diagnosis and must have shown some level of improvement after their initial treatment. They also need to have recovered from any side effects of previous treatments and meet certain health criteria, such as having good organ function. Participants will need to provide consent, and if they're minors, a parent or guardian will need to sign on their behalf. This trial is currently recruiting participants, and those who join can expect close monitoring throughout the treatment process to ensure their safety and well-being.

Gender

ALL

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