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Phase I Study of Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using Major Histocompatibility Complex (MHC) Mismatched Related Donors and Sub-Myeloablative Regimen


Phase 1
6 Months
17 Years
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

Phase I Study of Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using Major Histocompatibility Complex (MHC) Mismatched Related Donors and Sub-Myeloablative Regimen


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The immediate safety of a fludarabine based reduced intensity conditioning regimen and CD34+ stem cell selected mis-matched, related, allogeneic transplant will be assess in patients with relapsed/refractory neuroblastoma

Outcome Description:

Monitoring of mortality, toxicity (NCI Common Criteria), acute and chronic graft versus host disease, engraftment rate will contribute to safety assessment

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

STALLO

NCT ID:

NCT01462396

Start Date:

October 2011

Completion Date:

October 2014

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma
  • Relapsed
  • Refractory
  • Neuroblastoma

Name

Location

Children's Mercy HospitalKansas City, Missouri  64108