Status:
COMPLETED
Chemotherapy With CD133+ Select Autologous Hematopoietic Stem Cells for Children With Solid Tumors and Lymphomas
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
University of Miami
Conditions:
Neuroblastoma
Central Nervous System Tumors
Eligibility:
All Genders
Up to 25 years
Phase:
NA
Brief Summary
Studies have provided evidence that residual microscopic malignant cells in autologous bone marrow or blood stem cell grafts can contribute to posttransplant relapse. Researchers are currently explori...
Detailed Description
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 desc...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00152126
Start Date
August 1 2003
End Date
February 1 2009
Last Update
February 13 2009
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105