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

Primary Purpose

Neuroblastoma, Central Nervous System Tumors, Lymphomas

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stem Cell Transplantation
Busulfan, Melphalan
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring Autologous stem cell transplantation, CD133 cell selection, CliniMACS device, Tumor marker, Tumor purging

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
February 12, 2009
Sponsor
St. Jude Children's Research Hospital
Collaborators
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00152126
Brief Title
Chemotherapy With CD133+ Select Autologous Hematopoietic Stem Cells for Children With Solid Tumors and Lymphomas
Official Title
Busulfan and Melphalan With Autologous Hematopoietic Stem Cell Support With Positively-Selected CD133+ Hematopoietic Cells for Children With High Risk Solid Tumors and Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Jude Children's Research Hospital
Collaborators
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Central Nervous System Tumors, Lymphomas, Wilms Tumor
Keywords
Autologous stem cell transplantation, CD133 cell selection, CliniMACS device, Tumor marker, Tumor purging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Transplantation
Intervention Description
Autologous stem cell transplantation
Intervention Type
Drug
Intervention Name(s)
Busulfan, Melphalan
Other Intervention Name(s)
Autologous stem cell transplant, CD133+ antigen specific selection, Apheresis
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
25 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Hale, M.D.
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

Learn more about this trial

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

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