Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Ewing's Sarcoma, Soft Tissue Sarcoma, Hepatoblastoma, Hodgkin's Disease, Germ Cell Tumor
In brief
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.
Key facts
- Study ID
- NCT00179816
- Run by
- Ann & Robert H Lurie Children's Hospital of Chicago
- People needed
- 12
- Starts
- 1999-04-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2010-10-11
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Children's Memorial Hospital — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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