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CompletedNCT00152126Updated Feb 13, 2009

Chemotherapy With CD133+ Select Autologous Hematopoietic Stem Cells for Children With Solid Tumors and Lymphomas

An interventional study of Stem Cell Transplantation and Busulfan, Melphalan in Neuroblastoma, Central Nervous System Tumors and Lymphomas, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged Up to 25 Years. Per ClinicalTrials.gov, last updated 2009-02-13.

Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
Up to 25 Years
Sex
All
01

Study 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 exploring different methods in an attempt to purify or "purge" the stem cell product to minimize the risk of tumor contamination.

The CD133+ antigen is a protein contained on or "expressed" on numerous cells in the human body including specific hematopoietic progenitor (blood forming) cells. However, this antigen is not expressed on certain cancer cells including neuroblastoma. A technique using the investigational CliniMACS cell sorting device has been developed in an effort to filter out only those stem cells that express this CD133+ antigen in order to infuse a hematopoietic stem cell product with no tumor contamination potential.

The primary objective of this study is to establish safety of treating patients with a high dose chemotherapy regimen of Busulfan and Melphalan followed by autologous CD133+ hematopoietic stem cell support. Transplants recipients are expected to achieve engraftment as defined by an absolute neutrophil count of greater than or equal to 500/mm3 for three consecutive days by day 42-post infusion. Thus, safety of the treatment plan will be evaluated in terms of failure to engraft by this specific time period.

Read the 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 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.
02

Conditions studied

  • Neuroblastoma
  • Central Nervous System Tumors
  • Lymphomas
  • Wilms Tumor

Keywords

  • Autologous stem cell transplantation
  • CD133 cell selection
  • CliniMACS device
  • Tumor marker
  • Tumor purging
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 26 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    1

    Procedure: Stem Cell Transplantation · Drug: Busulfan, Melphalan

Interventions

  • ProcedureStem Cell Transplantation

    Autologous stem cell transplantation

  • DrugBusulfan, Melphalan

    Transplant recipients will receive high dose Busulfan and Melphalan followed by autologous CD133+ antigen specific hematopoietic stem cell infusion. The autologous graft product will be selected using the investigational CliniMACS device.

    Also known as: Autologous stem cell transplant, CD133+ antigen specific selection, Apheresis

06

What researchers measure

Primary outcomes

  1. To determine the safety of the treatment plan using Busulfan and Melphalan followed by infusion of CD133+ selected hematopoietic cells in patients with high-risk malignancies.

    Time frame: August 2005

07

Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00152126
Lead sponsor
St. Jude Children's Research Hospital
Collaborators
University of Miami
First posted
Sep 9, 2005
Start date
Aug 2003
Primary completion
Aug 2005
Completion
Feb 2009
Last update
Feb 13, 2009

Study contacts

Gregory Hale, M.D.
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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