Clinical trial · Interventional
Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Neuroblastoma and Sarcomas
Double Dose Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Stage Neuroblastoma and Sarcomas
NCT00165139CI-TRIAL-00002754completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to determine the short and long term side effects of a very intensive treatment, which includes combinations of chemotherapy drugs followed by radiation therapy and two transplants supported by peripheral blood progenitor cells (stem cells), for children with advanced stage neuroblastoma and sarcomas.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewings Sarcoma | Ewing Sarcoma | ALIAS | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Non-rhabdomyosarcoma Soft Tissue Sarcoma | Soft Tissue Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide (VP-16) | Drug | Etoposide | ALIAS |
| G-CSF (granulocyte-colony stimulating factor) | Drug | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the toxicity and feasibility of double dose chemo-radiotherapy with blood progenitor cell rescue in this patient population.
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated neuroblastoma Stage D \> 365 days * Previously untreated neuroblastoma Stage C at age \> 365 days with n-myc amplification * Previously untreated metastatic Ewings sarcoma/PNET * Previously untreated non-rhabdomyosarcoma soft tissue sarcoma * Confirmation of neuroblastoma at time of diagnosis by histologic specimen or with bone marrow specimen showing solid tumor. Confirmation of sarcoma by histologic specimen with evidence of metastatic disease be imaging study * Patient 19 years of age or younger * ANC \> 1000 * Platelet count \> 75,000 * SGOT \< 2.5 x ULN * Normal serum creatinine levels for age Exclusion Criteria: * Previous malignancy requiring nonsurgical treatment or bone marrow transplant. * Relapsed disease
References
Publications (0)
Data not yet available
No reference posted for this study.