Autologous Transplant Followed by Allogeneic Transplant for High Risk Neuroblastoma

Stopped early · Phase 1

Conditions studied: Neuroblastoma

In brief

Neuroblastoma is a malignant tumor of the sympathetic nervous system. It is the second most common malignant tumor of childhood. Although modest advances have been made over the past 20 years children with high-risk neuroblastoma continue to have an unsatisfactory long-term survival. This study will administer induction chemotherapy followed by high-dose (myeloablative) chemotherapy with autologous stem cell transplantation, followed by radiation therapy, then immunotherapy with a non myeloablative allogeneic stem cell transplant for treatment of neuroblastoma. The purpose of this clinical research trial is to study the feasibility of giving immunotherapy with a non-myeloablative allogeneic transplant (NAT/AlloSCT), following myeloablative therapy and autologous stem cell transplant (MAT/AutoSCT). This study will also determine the side effects as well as the response rate for each group of patients (treatment arm).

Key facts

Study ID

NCT00670410

Run by

Columbia University

People needed

15

Starts

2003-11-01

Expected to finish

2010-12-01

Last updated by the study team

2016-06-24

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age be < 30 years of age at the time of initial diagnosis.
• Patients must have a diagnosis of neuroblastoma (ICD-O morphology 9500/3) verified by histology and/or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Patients with the following disease stages at diagnosis are eligible, if they meet the other specified criteria. The revised International Neuroblastoma Staging System (INSS) will be used to stage all patients 58. (See 14.3 for risk assignment).
• Patients with newly diagnosed neuroblastoma and age > 547 days with the following:
• INSS Stage 4 neuroblastoma regardless of biologic factors
• INSS Stage 2A/2B with MYCN amplification (> 10)
• INSS Stage 3 with MYCN amplification (> 10) OR Unfavorable histology
• Patients with newly diagnosed neuroblastoma and age < 365 days with the following:
• INSS Stage 3, 4, OR 4S neuroblastoma AND MYCN amplification (> 10).
• Patients with newly diagnosed Neuroblastoma and age 365 - <547 days with the following:
• INSS Stage 3 with MYCN amplification (> 10)
• INSS Stage 4 with MYCN amplification (> 10) OR with deoxyribonucleic acid (DNA) Index (ploidy) = 1 OR with Unfavorable histology
• Patients > 365 days with INSS Stage 1, 2, and 4S who have progressed to Stage 4.
• Newly Diagnosed patients should be entered on this study within 4 weeks of diagnosis, or after receiving only one cycle of intermediate dose chemotherapy for patients initially treated on/according to the low or intermediate risk Children's Oncology Group (COG) neuroblastoma studies, or within 4 weeks of progression to Stage 4 for INSS Stage 1, 2, 4S.
• Patients treated with alternative induction regimens and/or consolidation regimens (AutoSCT) who were not enrolled at diagnosis but who achieve a complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) and meet all other criteria will be eligible for either the consolidation MAT/AutoSCT and NAT/AlloSCT immunotherapy or NAT/AlloSCT, which ever is clinically appropriate after discussion with the Principal Investigators.
• Liver Function: alanine aminotransferase (ALT) and bilirubin < 3x normal
• Cardiac Function: Shortening fraction > 27%, or ejection fraction > 47%, no clinical congestive heart failure.
• Renal Function: Creatinine clearance and/or glomerular filtration rate (GFR) > 60 ml/min/1.73m2.
• Hematologic Function: Patients must have adequate hematopoietic function (absolute neutrophil count (ANC) > 1000/mm3 and platelets > 100,000/mm3) unless inadequate hematopoiesis documented to be due to bone marrow involvement with tumor (> 10% tumor infiltration).

You may not qualify if…

• Patients who are pregnant. Patients of childbearing potential must practice an effective method of birth control while participating on this study.

Where it is running

• Columbia Presbyterian Medical Center, Morgan Stanley Children's Hospital New York Presbyterian — New York, New York, United States

Full record on ClinicalTrials.gov

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