Autologous Stem Cell Rescue With CD133+ Selected Cells in High-Risk Neuroblastoma
This study has been terminated.
(Slow Accrual.)
Sponsor:
M.D. Anderson Cancer Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
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 ]
| 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:
- 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:
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 May 23, 2013