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High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

Information source: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: Carboplatin (Drug); Autologous stem cell infusion (Biological); Granulocyte colony stimulating factor (Biological); Radiation therapy (Radiation); Isotretinoin (13-cis-retinoic acid) (Drug); Melphalan (Drug); Etoposide (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Masonic Cancer Center, University of Minnesota

Official(s) and/or principal investigator(s):
Michael R. Verneris, M.D., Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota

Overall contact:
Patricia Kleinke, Phone: 612-273-0857, Email: pkleink1@fairview.org

Summary

This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.

Clinical Details

Official title: High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Rescue for Neuroblastoma: Standard of Care Considerations

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Patients with Successful Engraftment

Secondary outcome:

Number of Patients with Disease Free Survival

Overall Survival

Number of Patients with Treatment Related Death

Number of Patients with Disease Free Survival

Overall Survival

Detailed description: This therapy involves the use of melphalan, etoposide, and carboplatin (consolidation chemotherapy); autologous stem cell rescue, post-transplant radiation therapy and a maintenance phase with Isotretinoin (Accutane, 13-cis-retinoic acid) therapy. If available, patients should also consider post-transplant therapy with cytokines and monoclonal antibody (ch14. 18) on a COG or New Approaches to Neuroblastoma Therapy (NANT) trial.

Eligibility

Minimum age: N/A. Maximum age: 30 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Less than 30 years of age at diagnosis of neuroblastoma

- No evidence of disease progression: defined as increase in tumor size of >25% or new

lesions

- Recovery from last induction course of chemotherapy (absolute neutrophil count > 500

and platelet > 20,000)

- No uncontrolled infection

- Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10^6 CD34 cells/kg for

transplant are mandatory and 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged)

- Adequate organ function defined as:

- Hepatic: aspartate aminotransferase (AST) < 3 x upper limit of institutional

normal 8 Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (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 Exclusion Criteria

- Patients with progressive disease should consider participating in phase I studies

since consolidation therapy using the regimen outlined in this document have not been determined to be useful.

- Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet

organ function criteria.

Locations and Contacts

Patricia Kleinke, Phone: 612-273-0857, Email: pkleink1@fairview.org

Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Michael R. Verneris, M.D., Phone: 612-626-2961, Email: verneris@umn.edu
Michael R. Verneris, M.D., Principal Investigator
Additional Information

Starting date: March 2012
Last updated: April 22, 2015

Page last updated: August 23, 2015

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