Autologous Stem Cell Rescue With CD +133 Selected Cells in High-Risk Neuroblastoma - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00539500

Purpose

Primary Objectives:

To determine the engraftment failure rate.
To evaluate the device-related toxicity associated with transplantation of CD133+ cells in high risk neuroblastoma.

Secondary Objectives:

To evaluate the time to failure, one-year overall and disease-free survival.
To evaluate the efficiency of purging of CD133+ selection by immunohistochemistry, flow and/or RT-PCR for tumor specific transcripts.
To document ClinicMACS device performance as assessed by yield and purity of CD133+ in a clinical cohort.

Condition	Intervention	Phase
Neuroblastoma	Drug: Carboplatin Drug: Etoposide Drug: Melphalan Procedure: Stem Cell Infusion Device: ClinicMACS	Phase II Phase III

MedlinePlus related topics: Cancer Neuroblastoma

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Autologous Stem Cell Rescue With CD133+ Selected Hematopoietic Progenitor Cells in Patients With High-Risk Neuroblastoma

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

Primary Outcome Measures:

To learn how long it takes for certain types of transplanted stem cells to produce new blood cells. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan	Drug: Carboplatin Carboplatin IV over 24 hours x 4 days, dosing as determined at day 1. Drug: Etoposide 300 mg/m^2 IV Over 24 Hours x 4 Days Drug: Melphalan 70 mg/m^2 IV Bolus x 3 Days 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

1: Experimental

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

Drug: Carboplatin

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

Drug: Etoposide

300 mg/m^2 IV Over 24 Hours x 4 Days

Drug: Melphalan

70 mg/m^2 IV Bolus x 3 Days

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.
Zubrod performance status </=2.
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

Contacts

Contact: Laura L. Worth, MD, PhD

713-792-7751

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Laura L. Worth, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Laura L. Worth, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

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

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Laura L. Worth, MD, PhD/Associate Professor )
Study ID Numbers:	2006-0374
Study First Received:	October 2, 2007
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00539500
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
Etoposide
Melphalan
CD +133 Cells

Study placed in the following topic categories:

Melphalan
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Carboplatin

Etoposide phosphate
Etoposide
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009