Autologous Stem Cell Rescue With CD133+ Selected Cells in High-Risk Neuroblastoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00539500

Purpose

The goal of this clinical research study is to learn how long it takes for certain types of transplanted stem cells to produce new blood cells. The safety of this treatment will also be studied. Finally, researchers want to learn if collecting the cells with the CliniMACS device can decrease the possibility of tumor cells contaminating (appearing in) the stem cells that are reinfused into participants.

Condition	Intervention	Phase
Neuroblastoma	Drug: Carboplatin Drug: Etoposide Drug: Melphalan Procedure: Stem Cell Infusion Device: ClinicMACS	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Autologous Stem Cell Rescue With CD133+ Selected Hematopoietic Progenitor Cells in Patients With High-Risk Neuroblastoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Melphalan Melphalan hydrochloride Etoposide Carboplatin Etoposide phosphate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Engraftment Failure Rate [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Device-related toxicity associated with transplantation of CD133+ cells [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Transplantation CD133+ cells Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan	Drug: Carboplatin Carboplatin by vein over 24 hours x 4 days, dosing as determined at day 1. Other Name: Paraplatin® Drug: Etoposide 300 mg/m^2 by vein over 24 Hours x 4 Days Other Name: VePesid® Drug: Melphalan 70 mg/m^2 Intravenous Bolus x 3 Days Other Name: Alkeran Procedure: Stem Cell Infusion Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0. Device: ClinicMACS Device used to process the blood and separate the CD 133+ cells needed for transplantation

Arms

Assigned Interventions

Experimental: Transplantation CD133+ cells

Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan

Drug: Carboplatin

Carboplatin by vein over 24 hours x 4 days, dosing as determined at day 1.

Other Name: Paraplatin®

Drug: Etoposide

300 mg/m^2 by vein over 24 Hours x 4 Days

Other Name: VePesid®

Drug: Melphalan

70 mg/m^2 Intravenous Bolus x 3 Days

Other Name: Alkeran

Procedure: Stem Cell Infusion

Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0.

Device: ClinicMACS

Device used to process the blood and separate the CD 133+ cells needed for transplantation

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed high-risk Neuroblastoma defined as: a. INSS 2A/2B older then 365 days with MYCN amplified, unfavorable histology, and any ploidy. b. INSS Stage 3, older than 365 days with MYCN amplification and/or unfavorable histology. c. INSS Stage 4 or 4S, less than 365 days of age, with MYCN amplification d. INSS Stage 4, over 365, regardless of MYCN amplification or histology.
Pre-transplant modalities may include surgery, chemotherapy, or radiation therapy. Radiation must not include lung fields. Only patients in CR, or PR at the primary site will be eligible.
Any recurrent neuroblastoma with at least a partial response to salvage therapy.
Lansky performance score greater than or equal to 50 for patients </= 16 years of age, or Zubrod performance status score of 0-2 for patients > 16 years of age.
No symptomatic pulmonary disease. FEV1, FVC, and DLCO >/= 50% of expected corrected for hemoglobin. If unable to perform pulmonary function test (most children < 6 years of age), pulse oximetry >/= 92% on room air.
Adequate cardiac function as demonstrated by left ventricular ejection fraction >/= 50% by echocardiogram.
Adequate hepatic function as defined as SGOT (AST) and SGPT (ALT)< 5 X upper limits of normal.
All patients and/or their parents or legal guardians must sign a written informed consent.
Females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization must have a negative urine pregnancy test within 30 days of registering. Patients will be informed of the risk of not using adequate contraception.

Exclusion Criteria:

Patient is pregnant or breast-feeding.
Active infection not controlled by antibiotics after seven days of therapy.
Brain metastases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539500

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Laura L. Worth, MD, PhD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00539500 History of Changes
Other Study ID Numbers:	2006-0374
Study First Received:	October 2, 2007
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Neuroblastoma
ClinicMACS
CliniMACS
Stem Cell Transplantation
Blood And Marrow Transplantation
Pediatric
Solid Tumors

Carboplatin
Paraplatin
Etoposide
VePesid
Melphalan
Alkeran
CD133+ Cells

Additional relevant MeSH terms:

Neuroblastoma
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
Etoposide
Etoposide phosphate
Melphalan

Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2012