Status:
COMPLETED
Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using MHC Mismatched Related Donors
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
University of Kansas
Conditions:
Neuroblastoma
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief Summary
Allogeneic stem cell transplantation has been explored for patients with high risk neuroblastoma. Results have been mixed, with only small series and case reports. Recent reports, however, especially ...
Eligibility Criteria
Inclusion
- Age 6 months - \<18 years
- Measurable tumor by routine imaging or bone marrow biopsy
- Patient must have an 3/6, 4/6, or 5/6 human leukocyte antigen (HLA)-mismatched related donor who is Epstein-Barr virus (EBV) seropositive
- Karnofsky score 60% or greater if 10yrs old or older, Lansky score 60% or greater if under 10yrs old
- Pulse ox \>90% on room air
- Recovered from toxic effects of prior chemotherapy
- Patient must not be pregnant
- Patient must be HIV negative
- Patient or responsible person must be able to understand and sign an informed consent
- Available donor without contraindication for stem cell collection
Exclusion
- Pregnant and lactating women.
- Human immunodeficiency virus (HIV) positive patient.
- Uncontrolled intercurrent infection.
- Renal failure (Creatine \> 1.5 or Creatinine Clearance \< 40 ml/min/1.73m2)
- Active hepatitis or cirrhosis with liver test values greater than 3 times normal
- NOTE: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion, after review by the Children's Mercy Hospital ethics board
- Donor Inclusion/Exclusion Criteria
- Donor must be in good health based on review of systems and results of physical examination, and routine testing per standards of good medical care.
- Female donors of childbearing age must have a negative pregnancy test and must not be lactating
- EBv seropositive
- Donor stem cells should be human leukocyte antigen (HLA) typed using molecular methods. See section 6.1.3 for HLA matching requirements.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01462396
Start Date
October 1 2011
End Date
December 1 2015
Last Update
July 18 2018
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108