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Busulfan and Melphalan With Autologous Hematopoietic Stem Cell Support With Positively-Selected CD133+ Hematopoietic Cells for Children With High Risk Solid Tumors and Lymphomas


N/A
N/A
25 Years
Not Enrolling
Both
Neuroblastoma, Central Nervous System Tumors, Lymphomas, Wilms Tumor

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Trial Information

Busulfan and Melphalan With Autologous Hematopoietic Stem Cell Support With Positively-Selected CD133+ Hematopoietic Cells for Children With High Risk Solid Tumors and Lymphomas


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

August 2005

Safety Issue:

Yes

Principal Investigator

Gregory Hale, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

ST133

NCT ID:

NCT00152126

Start Date:

August 2003

Completion Date:

February 2009

Related Keywords:

  • Neuroblastoma
  • Central Nervous System Tumors
  • Lymphomas
  • Wilms Tumor
  • Autologous stem cell transplantation
  • CD133 cell selection
  • CliniMACS device
  • Tumor marker
  • Tumor purging
  • Lymphoma
  • Wilms Tumor
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794