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Keep this study
Lead
St. Jude Children's Research Hospital
With
University of Miami
Secondary objectives for this protocol include the following:
* To describe CD133+ graft content post-selection and to describe the yield and purity of CD133+ content of the graft obtained.
* To describe the negative selection efficiency of this strategy by assessing the processed product for tumor specific markers, when applicable.
* To characterize the proliferation of clonal progeny of CD133+ cells.
* To characterize lymphocyte and hematopoietic reconstitution (including the kinetics of platelet engraftment) in these patients.
* To estimate one-year disease-free and overall survival in these transplant recipients.
Age
0–25
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eligibility will be determined separately for Part I and Part II of this study:
Part I ( Part I Eligibility criteria (eligibility for undergoing apheresis procedure)
Age ≤ 25 years at initial diagnosis.
Must have one of the following diagnoses:
High risk neuroblastoma
Metastatic or recurrent retinoblastoma
High risk rain tumors
Recurrent or refractory Hodgkin disease
Recurrent or advanced stage Wilms tumor
Recurrent or metastatic sarcomas
Recurrent or refractory non-Hodgkin lymphoma
Desmoplastic small round cell tumor.
Lansky or Karnofsky Performance Score ≥ 70.
Creatinine ≤ 2.0 mg/dl.
Direct bilirubin ≤ 2.0 mg/dl.
SGPT ≤ 2 x upper limit of normal
HIV testing
Negative pregnancy test
Patients with significant prior radiation therapy to the liver will be excluded.
Part II eligibility criteria (criteria for transplantation of CD133 select stem cell product)
Successfully completed Part I of protocol treatment plan and has the following available:
Stored autologous bone marrow or peripheral blood stem cells (i.e. 2 x 106 unselected CD34+ cells/ kg PBSC or 1 x 106 CD34+ cells/ kg BM) for back up.
Stored autologous bone marrow or peripheral blood stem cells (2 x 106 CD133+ cells/ kg PBSC or 2 x 106 CD133+ cells/ kg BM) for infusion.
Forced vital capacity greater than or equal to 40% normal or pulse oximetry greater than or equal to 92% on room air.
Lansky or Karnofsky Performance Score ≥ 70.
Creatinine ≤ 2.0 mg/dl.
Direct bilirubin ≤ 2.0 mg/dl.
SGPT ≤ 2 x upper limit of normal
Negative pregnancy test
Patients with significant prior radiation therapy (in opinion of the PI) to the liver will be excluded.
Clareo Health | Chemotherapy With CD133+ Select Autologous Hematopoietic Stem Cells for Children With Solid Tumors and Lymphomas
