Clinical trial · Interventional
Autologous Stem Cell Rescue With CD133+ Selected Cells in High-Risk Neuroblastoma
Autologous Stem Cell Rescue With CD133+ Selected Hematopoietic Progenitor Cells in Patients With High-Risk Neuroblastoma
NCT00539500CI-TRIAL-00039744terminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| ClinicMACS | Device | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Stem Cell Infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplantation CD133+ cells
- description
- Stem Cell Transplantation of CD133+ cells using the ClinicMACS in combination with Carboplatin + Etoposide + Melphalan
- interventionNames
- Drug: Carboplatin
- Drug: Etoposide
- Drug: Melphalan
- Procedure: Stem Cell Infusion
- Device: ClinicMACS
Primary outcomes (1)
- measure
- Engraftment Failure Rate
- timeFrame
- Participant evaluation at Day 42, total study up to 3 Years
- description
- Engraftment Failure Rate is number of participants with engraftment failure out of total participants. Engraftment failure is defined as failure to achieve an absolute neutrophil count (ANC) \>500/ul by day 42, and has no evidence of donor chimerism on bone marrow examination.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 complete response (CR), or partial response (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. forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and Carbon Monoxide Diffusing Capacity (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 serum glutamic-oxaloacetic transaminase, SGOT (AST) and serum glutamic-pyruvic transaminase, SGPT (ALT)\< 5 times 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.
References
Publications (0)
Data not yet available
No reference posted for this study.