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

NCT00152126 | Completed

• 1 other identifier: ST133
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma; Central Nervous System Tumors; Lymphomas; Wilms Tumor

Keywords

Autologous stem cell transplantation; CD133 cell selection; CliniMACS device; Tumor marker; Tumor purging

Outcome Measures

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.

  August 2005

Study Arms (1)

1

OTHER

Procedure: Stem Cell Transplantation; Drug: Busulfan, Melphalan

Interventions

Stem Cell Transplantation PROCEDURE

Autologous stem cell transplantation

1

Busulfan, Melphalan DRUG

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

1

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• University of Miami: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Neuroblastoma; Central Nervous System Neoplasms; Lymphoma; Wilms Tumor

Interventions

Stem Cell Transplantation; Busulfan; Melphalan; Blood Component Removal

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Gregory Hale, M.D.

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: August 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: February 1, 2009
• Last Updated: February 13, 2009

Record last verified: 2009-02

Locations

US (1)