Clinical trial · Interventional
Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors
High-Dose Chemotherapy With Tandem Peripheral Blood Stem Cell (PBSC) Rescue for the Treatment of High-Risk Pediatric Solid Tumors.
NCT00179816CI-TRIAL-00004014unknownPhase 1 / Phase 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)
This study uses a double autologous peripheral blood stem cell rescue (PBSC) following dose-intensive chemotherapy for the treatment of high-risk pediatric solid tumors.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing's Sarcoma | Ewing Sarcoma | ALIAS | 0.90 |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Hepatoblastoma | Hepatoblastoma | ONTOLOGY_EXACT | 0.98 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Dose Chemotherapy with Tandem PBSC Rescue. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the feasibility and toxicity of tandem PBSC rescue following high dose chemotherapy as consolidation in pediatric patients with high risk solid tumors.
- timeFrame
- annually
Secondary outcomes (2)
- measure
- Evaluate length of remission and long term disease free survival in chemotherapy responsive high-risk pediatric solid tumor patients treated using this approach.
- timeFrame
- Annually
- measure
- Evaluate correlation between cell dose and time to engraftment in high-risk pediatric solid tumor patients treated using this approach.
- timeFrame
- Time to engraftment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* Malignant Diseases:
* Ewing's sarcoma/PNET:
* CR1 - Metastatic disease at diagnosis, tumor volume \> 100 ml, pelvic bone primary
* CR2 - Locally recurrent disease
* Soft tissue sarcoma
* CR1 - Metastatic disease at diagnosis or locally advanced disease where local control is suboptimal (i.e., inability to provide radiation therapy due to extent of disease).
* CR2 - Locally recurrent disease (VGPR2 acceptable)
* Hepatoblastoma:
* VGPR1 - Patients with metastatic disease at diagnosis who have a persistently elevated alpha FP, or unresectable primary as a way of converting to resectable.
* CR2/VGPR2
* Hodgkin's Disease:
* VGPR1 - Progression on primary therapy/Refractory disease
* CR2/VGPR2
* Germ Cell Tumor:
* CR2/VGPR2 - recurrent disease
* Wilms Tumor:
* CR2/VGPR2 - recurrent disease
* IRB approved signed written informed consent by patient and/or their legally authorized guardian.
* Patients 21 years of age or younger at initial diagnosis, with older patients considered individually for primary pediatric disease diagnosis.
* Adequate central venous access (double lumen CVL or 2 single lumen PCVC).
* Adequate PBSC harvests with a minimum of 2.0 x 108 MNC/kg available for each PBSC rescue.
* Organ Function:
* Platelets \> 50,000/ml
* SGOT \< 10 x upper limits of normal
* Creatinine \< 1.5 x normal baseline
* Normal cardiac function in accordance with institutional policies
* Normal pulmonary function in accordance with institutional policies.
* Physiologic status:
* No active infections
* Adequate performance status as measured by Karnofsky (\> 70%) or Lansky scale (\> 60%) as appropriate for age.
* Bone Marrow Status
* No evidence of morphologic involvement with tumor at the time of transplant
Off Study Criteria:
* Severe toxicity. Contact the Study Coordinator immediately and complete Adverse Reaction Form.
* Disease progression or relapse prior to PBSC #1 or between PBSC rescue # 1 and #2.
* Inability to collect adequate numbers of PBSC for successful transplantation.
* Patient or parent/guardian refusal to remain on study.References
Publications (0)
Data not yet available
No reference posted for this study.