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

This study has been terminated.
(Slow Accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00539500
First received: October 2, 2007
Last updated: September 7, 2012
Last verified: September 2012
  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: 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:


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 ]

Enrollment: 3
Study Start Date: October 2007
Primary Completion Date: September 2012 (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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Any recurrent neuroblastoma with at least a partial response to salvage therapy.
  4. 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.
  5. 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.
  6. Adequate cardiac function as demonstrated by left ventricular ejection fraction >/= 50% by echocardiogram.
  7. Adequate hepatic function as defined as SGOT (AST) and SGPT (ALT)< 5 X upper limits of normal.
  8. All patients and/or their parents or legal guardians must sign a written informed consent.
  9. 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:

  1. Patient is pregnant or breast-feeding.
  2. Active infection not controlled by antibiotics after seven days of therapy.
  3. Brain metastases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: September 7, 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 July 26, 2014