Status:
TERMINATED
Autologous Transplant Followed by Allogeneic Transplant for High Risk Neuroblastoma
Lead Sponsor:
Columbia University
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Despite the modest advances made over the past two decades with the addition of more intensive chemotherapy and high dose myeloablative therapy with allogeneic or autologous bone marrow transplantatio...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Patients who are pregnant. Patients of childbearing potential must practice an effective method of birth control while participating on this study.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00670410
Start Date
November 1 2003
End Date
December 1 2010
Last Update
June 24 2016
Active Locations (1)
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1
Columbia Presbyterian Medical Center, Morgan Stanley Children's Hospital New York Presbyterian
New York, New York, United States, 10032